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Does Maintained Spinal Manipulation Therapy for Chronic Nonspecific Low Back Pain Result in Better Long-Term Outcome?
Abstract
A prospective single blinded placebo controlled study was conducted.
To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments.
SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied.
Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with "maintenance spinal manipulation" every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals.
Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.
SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.
... The average age of participants was 34.05 years old. Eight trials (27%) included acute or chronic neck pain [38][39][40][41][42][43][44][45]; seven (23%) acute or chronic low back pain [46][47][48][49][50][51][52]; six trials (20%) shoulder pain [53][54][55][56][57][58]; three (10%) headache [59][60][61]; two (7%) primary dysmenorrhea [62,63]; and trials looked at thoracic spine pain (3%) [64]; patellofemoral pain syndrome (3%) [65]; temporomandibular disorder (3%) [66]; and cervical radiculopathy (3%) [67]. ...
... The trials had to perform at least one manipulation in one intervention group and this procedure had to be the only one the subjects received. Most of the trials performed one session of treatment (63%) [38][39][40][41][42][43][44][45]50,52,54,55,[57][58][59]63,[65][66][67], the trial conducted by Senna et al. [51] the longest one, conducted over a 10-month period and completing 48 sessions of manipulations during this time. Concerning the pain emplacement and manipulation location: five trials (63%) which presented subjects suffering from neck pain performed cervical spine manipulation [38][39][40]43,44] and three (37%) applied thoracic spine manipulation [41,42,45]; in low back pain trials applied lumbar manipulation in all interventions [46][47][48][49][50][51][52]; ...
... Most of the trials performed one session of treatment (63%) [38][39][40][41][42][43][44][45]50,52,54,55,[57][58][59]63,[65][66][67], the trial conducted by Senna et al. [51] the longest one, conducted over a 10-month period and completing 48 sessions of manipulations during this time. Concerning the pain emplacement and manipulation location: five trials (63%) which presented subjects suffering from neck pain performed cervical spine manipulation [38][39][40]43,44] and three (37%) applied thoracic spine manipulation [41,42,45]; in low back pain trials applied lumbar manipulation in all interventions [46][47][48][49][50][51][52]; ...
Purpose:
Background: Evaluate whether the design of placebo control groups could produce different interpretations of the efficacy of manual therapy techniques.
Methods:
Nine databases were searched (EMBASE, CINAHL, PsycINFO, MEDLINE, PubMed, SCOPUS, WEB of SCIENCE, COCHRANE, and PEDro). Randomized placebo-controlled clinical trials that used manual therapy as a sham treatment on subjects suffering from pain were included. Data were summarized qualitatively, and meta-analyses were conducted with R.
Results:
53 articles were included in the qualitative analysis and 48 were included in the quantitative analyses. Manipulation techniques did not show higher effectiveness when compared with all types of sham groups that were analyzed (SMD 0.28; 95%CI [-0.24; 0.80]) (SMD 0.28; 95%CI [-0.08; 0.64]) (SMD 0.42; 95%CI [0.16; 0.67]) (SMD 0.82; 95%CI [-0.57; 2.21]), raising doubts on their therapeutic effect. Factors such as expectations of treatment were not consistently evaluated, and analysis could help clarify the effect of different sham groups. As for soft tissue techniques, the results are stronger in favor of these techniques when compared to sham control groups (SMD 0.40; 95%CI [0.19, 0.61]). Regarding mobilization techniques and neural gliding techniques, not enough studies were found for conclusions to be made.
Conclusions:
The literature presents a lack of a unified placebo control group design for each technique and an absence of assessment of expectations. These two issues might account for the unclear results obtained in the analysis.
... Standard medical care based on medication is more frequently used during the early stages of LBP (79,83,85), while interventions based on exercise therapy are commonly prescribed for chronic primary LBP (81,82,86,87). Fewer studies have examined the differences with sham/placebo interventions (88)(89)(90)(91)(92)(93), and a handful have contrasted SMT to mobilization techniques for LBP (94)(95)(96). The outcome measures generally assessed include subjective reports of pain intensity and disability (the latter via the use of the Roland-Morris and Oswestry questionnaires), which are also the outcomes of interest for the present review. ...
... Sham SMT has been more frequently explored as a placebo comparator in efficacy trials of SMT for LBP (108). It is common to use a similar hand placement and patient position for sham SM while applying biomechanically different forces (e.g., lower force or velocity, non-therapeutic direction, or point of application) or no force at all (88)(89)(90)92). Figure 2 illustrates the direction of the findings for each of the studies discussed below. ...
... The negative results may rather be explained by a period of treatment and follow-up that was likely too short (2 weeks) for patients with long pain duration (90). The efficacy of SMT for patients with chronic LBP was also examined over a longer period of time (10 months) (88). During the first month of treatment, two groups received the same SMT, and a third group was exposed to sham manipulation. ...
Spine pain is a highly prevalent condition affecting over 11% of the world's population. It is the single leading cause of activity limitation and ranks fourth in years lost to disability globally, representing a significant personal, social, and economic burden. For the vast majority of patients with back and neck pain, a specific pathology cannot be identified as the cause for their pain, which is then labeled as non-specific. In a growing proportion of these cases, pain persists beyond 3 months and is referred to as chronic primary back or neck pain. To decrease the global burden of spine pain, current data suggest that a conservative approach may be preferable. One of the conservative management options available is spinal manipulative therapy (SMT), the main intervention used by chiropractors and other manual therapists. The aim of this narrative review is to highlight the most relevant and up-to-date evidence on the effectiveness (as it compares to other interventions in more pragmatic settings) and efficacy (as it compares to inactive controls under highly controlled conditions) of SMT for the management of neck pain and low back pain. Additionally, a perspective on the current recommendations on SMT for spine pain and the needs for future research will be provided. In summary, SMT may be as effective as other recommended therapies for the management of non-specific and chronic primary spine pain, including standard medical care or physical therapy. Currently, SMT is recommended in combination with exercise for neck pain as part of a multimodal approach. It may also be recommended as a frontline intervention for low back pain. Despite some remaining discrepancies, current clinical practice guidelines almost universally recommend the use of SMT for spine pain. Due to the low quality of evidence, the efficacy of SMT compared with a placebo or no treatment remains uncertain. Therefore, future research is needed to clarify the specific effects of SMT to further validate this intervention. In addition, factors that predict these effects remain to be determined to target patients who are more likely to obtain positive outcomes from SMT.
... 24 studies were included in this review (figure 1), one study had a 2×2 factorial design, 24 eight studies had multiple arms. [25][26][27][28][29][30][31][32] Most of the studies were conducted in physical therapy clinics, in 13 different countries. Three trials did not report in which clinical setting they were conducted. ...
... 40-42 44 Two trials used an ST with similar forces applied in different directions. 25 32 One trial did not specify the inactive manipulation applied. 29 In trials that provided multiple techniques in the same treatment session (such as osteopathic treatment, spinal Manual and controls treatments Different manual treatments were provided: ► SM/chiropractic (7 studies, 567 participants). ...
... 26 36 37 45 Senna and Machaly reported the most common AEs were local discomfort and tiredness but no serious complications were noted. 32 Haller et al reported two patients dropping out from the trial for recurrent headache after treatments, both Haller et al and Klein et al reported dizziness of one patient. 36 37 Licciardone et al reported 27% of patients with AE, 2% had serious AE not related to study interventions. ...
Objective
To assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.
Design
Systematic review and meta-analysis.
Methods and analysis
Different databases were screened up to 20 August 2020. Randomised controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included.
Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology and reflexology) and to no treatment. Primary outcomes were BP improvement, success of blinding and adverse effect (AE). Secondary outcomes were number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.
Results
24 trials were included involving 2019 participants. Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI −20.46 to 8.78).
ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique.
Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).
Conclusions
MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings.
Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.
PROSPERO registration number
CRD42020198301.
... 29) In addition, spinal mobilization generally requires longer treatment time, gentler touch by the clinicians and a more comfortable position for the patient than manipulation, which might lead to different effects between these manual therapy techniques. 30) Marshall and Murphy 16) assessed lumbopelvic muscle activity during various core stability exercises with and without a Swiss ball. The researchers reported that although there was an evidence suggesting that the Swiss ball provided a training stimulus for the rectus abdominis, the relevance of this change to core stability training required further research because the focus of stabilization training was on minimizing rectus abdominis activity. ...
... The authors found that motor control exercise and spinal manipulative therapy produced slightly better short-term, but not medium-or long-term, effects in patients with chronic non-specific back pain. Senna and Machaly 30) determined the effectiveness of maintenance spinal mobilization therapy in long-term reduction of pain and disability levels as-sociated with chronic low back conditions after an initial phase of treatments. They stated that spinal mobilization therapy was effective for the treatment of chronic non-specific LBP. ...
... While in some studies, 4,8,9,30) Our trial has several strengths, including four different types of management, including homogenous groups and a rigorous design with emphasis on internal validity. We also had excellent engagement and follow-up rates. ...
Background:
The purpose of this study was to compare the effectiveness of rehabilitation approaches in individuals with low back pain (LBP) on pain, spinal mobility, disability, and muscular strength.
Methods:
Ninety volunteers were included and divided into four groups depending on the rehabilitation approach. Group 1, soft tissue mobilization techniques and stabilization exercises (n=24; 11 females (F), 13 males (M); group 2, Kinesio Taping and stabilization exercises (n=24; 12F, 12M); group 3, stabilization exercises (n=22; 11F, 11M); and group 4, reflex therapy and stabilization exercises (n=20; 10F, 10M). Visual Analog Scale for pain intensity, an isokinetic evaluation for strength at 60°/s and a side-plank position test for trunk stabilization were measured before and assessed at the beginning, after a 4-week treatment and during 4 weeks of follow-up. The functional status was evaluated with the Oswestry Disability Index.
Results:
Individuals in all groups showed similar decrease in pain after the treatment and at 1-month follow-up, but there were no significant differences in pain levels between the groups (P<0.05).
Conclusion:
All therapeutic approaches were found to be effective in diminishing pain and thus helpful in increasing strength and stabilization in patients with LBP.
... Eight studies collected their data from chiropractors [8][9][10][11][12][13][14][15], who either estimated their responses or consulted their patient files, four studies collected their data from patients [16][17][18][19], in one study data were collected from both chiropractors and their patients [20], and one study used workers' compensation claims data [21]. Please see Table 1 for a description of the included studies. ...
... In this new review, we found four RCTs that investigated the clinical outcome of repeated treatments over a prolonged period. These trials are summarized in Table 2. Two studies investigated the outcome on patients with LBP [16,18], one studied NP [19], and one study included patients with both LBP and NP [17]. ...
... One study compared groups who received either Maintenance Care or self-managed appointments [16], and three studies compared groups with different content and treatment duration [17][18][19]. However, only one of these studies [14] used the inclusion criteria for Maintenance Care that were identified through the Nordic Maintenance Care Program. ...
Background:
Maintenance Care is a traditional chiropractic approach, whereby patients continue treatment after optimum benefit is reached. A review conducted in 1996 concluded that evidence behind this therapeutic strategy was lacking, and a second review from 2008 reached the same conclusion. Since then, a systematic research program in the Nordic countries was undertaken to uncover the definition, indications, prevalence of use and beliefs regarding Maintenance Care to make it possible to investigate its clinical usefulness and cost-effectiveness. As a result, an evidence-based clinical study could be performed. It was therefore timely to review the evidence.
Method:
Using the search terms "chiropractic OR manual therapy" AND "Maintenance Care OR prevention", PubMed and Web of Science were searched, and the titles and abstracts reviewed for eligibility, starting from 2007. In addition, a search for "The Nordic Maintenance Care Program" was conducted. Because of the diversity of topics and study designs, a systematic review with narrative reporting was undertaken.
Results:
Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary/tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor 'when needed'. No studies were found on the cost-effectiveness of Maintenance Care.
Conclusion:
Knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.
... According to the JADAD scale 19) , every study [20][21][22][23][24][25] , except the one by Lawand et al. 23) , was of a reasonable quality, as they all obtained 4 points. All of them showed that it was impossible to get a double blind, i.e., it was not possible to blind neither the subjects nor the therapists. ...
... This was possible because the above mentioned randomized control trial did not describe the method of blinding appropriately, contrarily to the rest of randomized control trials. The Table 1 shows the methodological quality analysis of the study [20][21][22][23][24][25] . ...
... The study conducted by Oliveira et al. 20 ) , proved that high-velocity spinal manipulation techniques are effective in the short term when performed on the low back region, as well as from a distance on the dorsal region. This research is connected in a linear manner to the one carried out by Senna y Machaly 25) , given that a substantial reduction in pain was achieved only in the group subjected to a maintained spinal manipulation therapy immediately after finishing the study, and not in the long term or the medium term. The study conducted by Bronfort et al. 24) , determined that there was no pain relief neither with long-term nor with short-term manipulations. ...
Introduction:
Chronic low back pain is a pathological process that compromises the functionality and quality of life worldwide. The objective of the study was to evaluate the effectiveness of classical physiotherapy in the management of non-specific chronic low back pain.
Methods:
A literature search in English electronic databases was performed from November to December of 2015. Only those studies addressing chronic non-specific low back pain by manual therapy and different types of exercises methods were included, and those, which combined acute or subacute pain with systematic reviews and clinical practice guidelines, were excluded. Studies involving cognitive-behavioral approaches were also excluded.
Results:
487 studies were identified, 16 were analyzed and 10 were excluded. Of the 6 studies reviewed, 5 of them achieved a moderate quality and 1 of them was of a low quality. Back School exercises and McKenzie's method were all ineffective. Osteopathic spinal manipulation proved effective when performed on the lower back and the thoracic area but only immediately after it was received, and not in the medium or long term. Massages proved effective in the short term too, as well as the global postural reeducation although ultimately this study can be considered of a low methodological quality.
Conclusions:
Based on the data obtained, classical physiotherapy proposals show ineffectiveness in the treatment of chronic non-specific low back pain. More multidimensional studies are needed in order to achieve a better treatment of this condition, including the biopsychosocial paradigm.
... Research by Ghroubi et al. (2007) showed positive results regarding reducing local back pain in humans by 22% and radiating pain by 35% via manual therapy over six months. Other authors have also concluded that manual treatment is clinically effective in treating patients with back pain in the short term (Senna and Machalyn 2011). Still, therapy sessions should be repeated at least every two weeks (De Heus et al. 2010;Haussler 2010;Senna and Machalyn 2011;Haussler 2020). ...
... Other authors have also concluded that manual treatment is clinically effective in treating patients with back pain in the short term (Senna and Machalyn 2011). Still, therapy sessions should be repeated at least every two weeks (De Heus et al. 2010;Haussler 2010;Senna and Machalyn 2011;Haussler 2020). ...
A horse needs to move in different gaits and carry a rider during riding. Therefore, the equine back must be in a good functional state. Preventing back disorders is one of the keys to ensuring a horse’s health. This study aimed to assess cranial osteopathy therapy as a treatment and prevention method for preventing and reducing back pain. Thirty-two thoroughbred horses were categorised by their backs’ functional status (16 without back pain and 16 with back pain). The mechanical nociceptive threshold was determined before and after osteopathic treatment by an algometer (pain test FPX 100) with pressure points between T14-T15, T18-L1, and L5-L6. The data were analysed with a significance of P < 0.05. The study found that cranial osteopathic therapy raised the mechanical nociceptive threshold average in 83.3% measured points for horses without back pain and in 50% measured points for those with back pain. This study revealed that both horses without back pain and horses with back pain had a positive response to cranial osteopathic therapy, as evidenced by the increased nociceptive threshold limits, indicating that osteopathic therapy can be used as a primary or additional treatment method for back dysfunction.
... Sham mobilization included only hand contact or active or passive ROM movements where there would be no therapeutic effects, as indicated in the literature [4,33]. Sham treatments and evaluations were performed by the same specialist physiotherapist. ...
... The study protocol included a Sham MWM treatment, which was applied with an active placebo approach similar to the real one. Several comparisons of spinal mobilization with sham mobilization have been used previously [4,19,33]. Although the study did not evaluate the effect on pain, it did compare the functional effect of spinal mobilization with sham mobilization, especially for the first month [36]. ...
... 44 And there are additional questions surrounding the Office of the Inspector General reports of chiropractors billing for maintenance care (sometimes called extended maintenance or preventive or wellness care). 45 Typically, chiropractors stop billing Medicare for extended maintenance care following the Centers for Medicare and Medicaid Services guidance to have patients sign an Advance Beneficiary Notice of Noncoverage form acknowledging that Medicare does not pay for this service. However, there are some patients who opt for this chiropractic service and pay for it out of pocket. ...
... 46 Further studies by physical therapists and chiropractors have shown that patients have less time lost from work and less disability when they receive spinal mobilization less frequently but on an extended basis after their initial care is completed. [45][46][47][48] ...
Objective
The purpose of this article is to discuss evidence that supports the resolution of inequities for Medicare beneficiaries who receive chiropractic care.
Discussion
Medicare covers necessary examinations, imaging, exercise instruction, and treatments for beneficiaries with back pain when provided by medical doctors, osteopaths, and their associated support staff such as nurse practitioners, physician assistants, clinical nurse specialists, and physical therapists. However, if the same patient with back pain presents to a chiropractor, then the only service that is covered by Medicare is manipulation of the spine. Current evidence does not support this inequity in Medicare beneficiary service coverage. There is no evidence to show an increase in serious risks associated with chiropractic treatment of neck or back pain in Medicare beneficiaries. Chiropractors support national public health goals and endorse safe, evidence-based practices. Chiropractic care for Medicare beneficiaries has been associated with enhanced clinical outcomes such as faster recovery, fewer back surgeries a year later, reduced opioid-associated disability, fewer traumatic injuries and falls, and slower declines in activities of daily living and disability over time. Further evidence points to lower costs, fewer medical physician visits for low back pain, less opioid-related expense, and less back-surgery expense with chiropractic utilization. Use is lower among vulnerable populations: seniors, lower income women, and black and Hispanic beneficiaries who may be most affected by current inequities associated with the limited coverage. In this era of evidence-based and patient-centered care, beneficiaries who receive chiropractic care are very satisfied with the care they receive.
Conclusion
The current evidence suggests a need for change in US policy toward chiropractic in Medicare and support for HR 3654. Ending inequities by providing patients full coverage for chiropractic services has the potential to enhance care outcomes and reduce health disparities without increasing program costs.
... The ES of the primary outcome of this study measured at 7 weeks was large (0.96), which is noteworthy. The ESs of primary outcomes at 1 month were 0.22, 0.28 [45,46] in a study selecting sham manipulative therapy as a control and 0.35 [46] in a study selecting manipulative method plus UC as a control, similarly to our design. In particular, the ESs of outcome with various interventions were 0.03-0.57 ...
... Regarding a suitable placebo for a trial of manipulative therapy, no consensus has existed among experts, including both clinicians and academics. Of the pragmatic RCTs of manipulative therapy, we found two studies of manipulative therapy included a placebo intervention for chronic LBP [45,50]. We carefully note that gap between ESs mentioned above could imply the placebo effect by unblinding. ...
Current evidence on the effectiveness and safety of Chuna manipulative therapy (CMT) for managing non-acute lower back pain (LBP) is insufficient. We investigated the comparative effectiveness and safety of CMT, a Korean style of manipulation, plus usual care (UC) compared to UC alone for non-acute LBP. We conducted a parallel, two-armed, multi-centered, assessor blinded, pragmatic, randomized controlled trial at four major Korean medical hospitals. Overall, 194 patients were randomly allocated to either CMT plus UC (n = 97) or UC alone (n = 97), for six weeks of treatment and six months follow-up. The primary outcome was measured using the numerical rating scale (NRS) of LBP intensity at 7 weeks. Secondary outcomes included NRS of leg pain, Oswestry Disability Index (ODI) for functional disability, patient global impression of change (PGIC) scale, and safety. A total of 194 patients were included in the intention-to-treat analysis, and 174 patients provided complete data for the primary outcome. At 7 weeks, clinically significant differences between groups were observed in the NRS of LBP (CMT + UC: -3.02 ± 1.72, UC: -1.36 ± 1.75, p < 0.001), ODI scores (CMT + UC: -5.65 ± 4.29, UC: -3.72 ± 4.63, p = 0.003), NRS of leg pain (CMT + UC: -2.00 ± 2.33, UC: -0.44 ± 1.86, p < 0.0001), and PGIC (CMT + UC: -0.28 ± 0.85, UC: 0.01 ± 0.66, p = 0.0119). Mild to moderate safety concerns were reported in 21 subjects. CMT plus UC showed higher effectiveness compared to UC alone in patients with non-acute LBP in reducing LBP and leg pain and in improving function with good safety results using a powered sample size and including mid-term follow-up.
... Present clinical practice guidelines recommend spinal manipulative therapy (SMT) as a primary intervention for low back pain [4][5][6]. SMT may reduce pain and disability in chronic low back pain patients [7,8]. A systematic review concluded that improvement in pain and function following SMT, in comparison with other interventions, might not be considered clinically relevant due to limited level of improvement and small effect size [9]. ...
... Similarly, our results did not show group-related differences, but a main effect for time in measures of clinical pain and disability over the three weeks of the study. Despite some past clinical trials [7,8] reporting that SMT appears efficacious for managing low back disorders, our results were similar to a previous clinical trial [29]. Bialosky et al. [29] did not observe group-related differences over a 2-week study examining the effects of SMT on clinical pain and disability. ...
Objectives: The long-term goal of our study is to improve the understanding of the biological mechanisms associated with spinal manipulative therapy (SMT) in low back pain.
Methods: This project involved a pilot randomized, blinded clinical trial (ClinicalTrials.gov registration number NCT03078114) of 3-week SMT in chronic nonspecific low back pain (CNSLBP) patients. We recruited 29 participants and randomly assigned them into either a SMT (n = 14) or sham SMT (n = 15) group. Pre- and postintervention, we quantified the effect of SMT on clinical outcomes (Numeric Pain Rating Scale and Oswestry Disability Index) and pressure pain threshold (PPT) at local (lumbar spine), regional (lower extremity), and remote (upper extremity) anatomical sites.
Results: We observed a significant main effect for time signifying reduced hypersensitivity (increased PPT) at local (p = .015) and regional (p = .014) locations at 3 weeks. Furthermore, we found significant main effects of time indicating improvements in pain (p < .001) and disability (p = .02) from baseline among all participants regardless of intervention. However, no between-group differences were observed in PPT, clinical pain, or disability between the SMT and sham SMT groups over 3 weeks.
Conclusions: After 3 weeks of SMT or sham SMT in CNSLBP patients, we found hypoalgesia at local and remote sites along with improved pain and low back-related disability.
Level of Evidence: 1b
... A personalized MC can be viewed as a form of preventive visit after the initial treatment for recurrent or episodic pain and musculoskeletal dysfunction [9]. The prevention of further episodes (secondary prevention) and associated sequelae (tertiary prevention) is equally important [21]. The MC strategy required only a slightly higher number of chiropractor visits and should be considered an adjuvant treatment option for patients with recurrent or persistent spinal pain who respond well to the initial course of chiropractic care [9]. ...
The present case study aimed to demonstrate the subtle effectiveness of 13-year chiropractic maintenance care (MC) in a patient with cer-vical radiculopathy associated with retrolisthesis. Retrolisthesis is the backward slippage of one vertebral body with respect to the subjacent vertebra. This slippage can lead to spinal nerve root compression or irritation (radiculopathy). A 44-year-old woman presented with relapsing episodes of pain in her neck radiating down her right arm and hand for 12 months. Neurological examination revealed sensory deficits in the right C5 dermatome. Cervical radiography showed grade 1 retrolisthesis of C3 on C4 and of C4 on C5, and sclerosis over the upper endplate of the C4, C5, and C6 vertebrae. The patient was diagnosed with right C5 radiculopathy associated with vertebral retrolisthesis. She was conservatively treated with multimodal chi-ropractic care comprising cervical manipulation applied to the affected segments, axial distraction, and isometric stretching. After 20 sessions over 3 months of therapy, the patient experienced complete relief of neck pain and radicular symptoms, and full cervical mobility. Because her complaints were characterized by relapsing episodes, she was enrolled in a monthly MC program to monitor and ensure the spine was functioning at its highest capacity. The MC program included disease monitoring, manipulation of dysfunctional segments, cervical strengthening exercises, and ergonomics coaching. Monthly care was shown to be successful in maintaining an asymptomatic status. Moreover, a gradual reduction in cervical retrolisthesis was observed during the 13-year MC period, and the ongoing MC ensured optimal spine functioning.
... If effectiveness is demonstrated by the innovative design based on SPIRIT guidelines, osteopathy could be integrated into the management of IBS patients. In addition, this study design takes into account recent RCTs of good methodological quality that have evaluated the effectiveness of non-pharmacological interventions such as osteopathy on functional disorders including IBS. 20 Our choice of a control group (SOT) whose patients' expectations and experiences are comparable to the experimental group (AOT) will address the methodological weaknesses identified in the current literature and provide an optimal control group that will allow us to accurately measure the clinical effectiveness of osteopathy on IBS symptoms. Furthermore, the recruited patients will all have the same level of baseline symptom severity as a recent systematic review has suggested that these expectations may be influenced by this factor. ...
p> Background: Osteopathy is chosen by patients as a treatment for irritable bowel syndrome (IBS) but evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.
Methods: Design: a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group included active osteopathic treatment. Control group included sham osteopathic treatment. Randomization was in allocation ratio 1:1. Assessment time was carried as inclusion and baseline assessment (day-1; initial visit V0), day 8, day 15 and follow-up (1 month and 3 months), treatments (day 0, day 8, day 15). Primary endpoint was effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint was effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size was 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).
Conclusions: The two-group parallel, randomized, double-blind, placebo-controlled trial (sham therapy) in which the expectations and experiences of patients in the control group are comparable to the experimental group is the most accurate design for demonstrating the effectiveness of osteopathy on IBS symptoms. Future studies could use such a design to assert causality.
Trial registration: The trial has been registered in clinicalTrials.gov. Registration number: NCT05230277; registered on 7 February 2022.</p
... 14 Study concluded that the manual thrust manipulation provides greater short-term reductions in self-reported disability and pain scores compared to the usual medical care. 15 Further confirms the above finding that SM therapy is effective for the treatment of chronic nonspecific LBP. Effectiveness of SWD as an individual treatment method for the chronic low back pain was demonstrated in the past studies. ...
p> Background: Chronic postural low back pain (CPLBP) is one of the common health problems worldwide. The aim of the study was to compare the spinal manipulation (SM) and short-wave diathermy (SWD) in patients with CPLBP in department of physical medicine at teaching hospital, Kandy, Sri Lanka.
Methods: Observational study was conducted. Patients diagnosed as CPLBP, who referred to the department of physical medicine (DPM), teaching hospital Kandy, were observed in the study (n=140). Seventy (70) patients were allocated for SWD and 70 for SM by the consultant. Two physiotherapists were routinely appointed for the treatments and SWD treatment by group 1 and SM was carried out by group 2. The two treatment sessions were continued once a week through four weeks. Outcomes were measured by numerical pain scale to compare with initial pain.
Results: Group 1, SM consisted 39 females and 31 males, group 2, SWD 40 females and 30 males. After 4 sessions, the mean value of pain reduction from initial pain was significantly high (p<0.001) in SM group than the short-wave diathermy group in both genders. (Female: 6.410 (SM) and 4.625 (SWD), Male:6.710 (SM) and 4.333 (SWD). Further the mean values showed that there was a significant pain reduction during the initial treatment session than 2<sup>nd</sup>, 3<sup>rd</sup>and final sessions in both treatment groups.
Conclusions: Pain reduction was more pronounced in the first treatment session in both methods. SM is more effective for the treatment of CPLBP irrespectively the age and gender when compare to the SWD in the study population. Therefore, SM could apply on CPLBP patients with higher effective treatment.</p
... This is an important gap in evidence because the greatest risk factor for experiencing an episode of LBP is history of LBP [19], and between 50% and 70% of those with LBP suffer a recurrence within 12 months [20,21]. A small cadre of studies on CCPM for patients with cLBP, including two small pilot studies and one RCT of 328 participants, indicate that CCPM may improve outcomes [22][23][24][25]. However, these studies did not focus on veterans and were conducted outside the United States. ...
Conflicts of interest: No potential conflicts exist for any author listed.Abstract
Background
Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain.
Design
This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52.
Summary
This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.
... 11 Frequency of extended care has been described to range from 1 session every 2 weeks to 1 session every 3 months. 13,[29][30][31][32][33] We chose to set visit frequency to a maximum of 1 session per month, influenced by these previous descriptive reports. However, there is no substantiated evidence to support our defined frequency. ...
Objective
The purpose of this article is to describe the management of chronic spine pain in 3 United States military veterans who participated in extended courses of chiropractic care that focused on active care strategies in a group setting.
Clinical Features
A 68-year old male veteran (case 1) with a 90% service-connected disability rating presented with chronic neck and lower back pain. An 82-year old male veteran (case 2) with a 20% service-connected disability rating presented with chronic neck and upper back pain. A 66-year old male veteran (case 3) presented with a 10% service-connected disability with chronic episodic back and neck pain. Each veteran described a desire to maintain ongoing chiropractic treatments after completion of a course of chiropractic care in which maximal therapeutic gain had been determined. Patient-Reported Outcomes Measurement Information System (PROMIS) Patient Interference Short Form 6b (PPI), PROMIS Physical Function Short Form 10b (PPF), and Pain, Enjoyment, and General Activity (PEG) outcome measurement tools were used to track response to care.
Interventions and Outcome
Each veteran participated in an extended course of chiropractic visits consisting of group pain education, group cognitive behavioral strategies, group exercise, group mind-body self-regulation therapy, and optional individual manual therapy. Case 1 completed 8 extended chiropractic visits in 12 months and reported no change in PPI scores, improvement in PPF scores, and worsening PEG scores. Cases 2 and 3 completed 6 extended chiropractic visits each over a 12-month period and reported improvements in PPI, PPF, and PEG scores.
Conclusion
This article describes the responses of 3 veterans with chronic spine pain participating in long-term care using chiropractic visits in a group setting that focused on active care strategies. Our group-based, active care approach differs from those described in literature, which commonly focus on visits with a strong emphasis on manual therapy in 1-on-1 patient encounters.
... 9 The benefits of spinal manipulation include reductions in pain and disability, and these benefits are comparable with most recommended therapies for chronic low back pain in both the short and long term. 10,11 The most recent overview of clinical practice guidelines for people with low back pain 12 found that a third of the existing guidelines recommend spinal manipulation as a component of a multimodal program for patients with chronic low back pain. 3,13 However, as the site of pain is usually very sensitive, there is still debate about the need for specific manipulation (ie, at the site of the painful vertebral segment). ...
Question
In people with chronic low back pain, what is the average effect of directing manipulation at the most painful lumbar level compared with generic manipulation of the spine?
Design
Randomised controlled trial with concealed allocation, a blinded assessor and intention-to-treat analysis.
Participants
148 people with non-specific chronic low back pain with a minimum level of pain intensity of 3 points (measured from 0 to 10 on the Pain Numerical Rating Scale).
Interventions
All participants received 10 spinal manipulation sessions over a 4-week period. The experimental group received treatment to the most painful segment of the lower back. The control group received treatment to the thoracic spine.
Outcome measures
The primary outcome was pain intensity, measured at the end of the intervention (Week 4). Secondary outcomes were: pain intensity at Weeks 12 and 26; pressure pain threshold at Week 4; and global perceived change since onset and disability, both measured at Weeks 4, 12 and 26.
Results
Each group was randomly allocated 74 participants. Data were collected at all time points for 71 participants (96%) in the experimental group and 72 (97%) in the control group. There were no clinically important between-group differences for pain intensity, disability or global perceived effect at any time point. The estimate of the effect of directing manipulation at the most painful lumbar level, as compared with generic manipulation, on pain intensity was too small to be considered clinically important: MD 0 (95% CI −0.9 to 0.9) at Week 4 and −0.1 (95% CI −1.0 to 0.8) at Week 26.
Conclusion
No clinically important differences were observed between directed manipulation and generic manipulation in people with chronic low back pain.
Trial Registration
NCT02883634.
... Bracing --Lumbosacral brace --Sacroiliac brace 29 There is conflicting evidence that bracing results in improvements in pain and function in patients with subacute low back pain. [166][167][168] Grade of Recommendation: I v. SMT [86,89,[168][169][170][171][172][173][174][175][176][177][178][179][180][181][182] For patients with acute or chronic low back pain, spinal manipulative therapy (SMT) is an option to improve pain and function. ...
Background context
The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016.
PURPOSE
The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition.
Study design
This is a guideline summary review.
Methods
This guideline is the product of the Low Back Pain Work Group of NASS’ Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors.
Results
Eighty-two clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature.
Conclusions
The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with nonspecific low back pain. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx
... These patients often benefit from 1 to 2 visits per month to providers of nonpharmacologic conservative care who use spinal manipulation, to be reevaluated every 6 to 12 visits. [18][19][20][21][22][23] History A thorough history and examination based on evidence-informed procedures are critical to appropriate chiropractic management of patients with neck pain. Depending on the complexity of the case, components of the history may include (1) assessment of red flags and yellow-flag risk factors; (2) onset of current neck pain/mechanism of injury; ...
Objective:
The purpose of this study was to develop best-practice recommendations for chiropractic management of adults with neck pain.
Methods:
A steering committee of experts in chiropractic practice, education, and research drafted a set of recommendations based on the most current relevant clinical practice guidelines. Additional supportive literature was identified through targeted searches conducted by a health sciences librarian. A national panel of chiropractors representing expertise in practice, research, and teaching rated the recommendations using a modified Delphi process. The consensus process was conducted from August to November 2018. Fifty-six panelists rated the 50 statements and concepts and reached consensus on all statements within 3 rounds.
Results:
The statements and concepts covered aspects of the clinical encounter, ranging from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral for patients presenting with neck pain.
Conclusions:
These best-practice recommendations for chiropractic management of adults with neck pain are based on the best available scientific evidence. For uncomplicated neck pain, including neck pain with headache or radicular symptoms, chiropractic manipulation and multimodal care are recommended.
... But did not close the possibility to get the effect in a long time. The research is conducted by (Senna & MacHaly, 2011) to see the possibility of results in a long time. In the study there were 60 samples with CNLB selected at random. ...
Background: Low back pain (LBP) is one of the many spinal cord-positioning conditions commonly experienced by adults. Age factors affect the seriousness of trauma to the spine as in patients with osteoporosis under unusual conditions caused by radiculopathy or spinal stenosis, fracture, tumor or infection. This article aimed to identify the most effective non-invasive treatment in treating pain in Low Back Pain (LBP). Methods: cirtical review was used in making this article. Articles were collected through Medline, Google Scholar, Science Direct, Pubmed databases using the keywords: treatment, non-invasive, Low Back Pain from the quantitative studies. The selected articles were those that met the criteria based on PICO, published in the 2010-2017, and used English language. Articles were then evaluated using critical appraisal and PRISMA guides. Based on the evaluation, there are 6 (six) articles that match the purpose and criteria of review. From the literature search results found ways to reduce pain through non-invasive treatment such as Acupunture, Massage, Spinal Manipulation and Yoga can reduce LBP pain. Conclusion: The result of the literature that the most effective method of reducing pain is spinal manipulation where the effect of reducing pain can be maintained for a long time and is more applicable because without the use of aids, nevertheless treatment combined with other treatments and done on an ongoing basis will better results.Keywords: treatment, non infasif, Low Back Pain
... ). L'amplitude cervicale pourrait 28 probablement être améliorée après plusieurs séances de manipulations et sur une plus longue durée. En effet, dans les lombalgies chroniques, une étude a démontré que des manipulations consécutives de la région lombaire induisent de meilleurs résultats à long terme(Senna & Machaly, 2011).En ce qui concerne la mécano-sensitivité du tronc et du membre supérieur ainsi que la force de préhension, les manipulations cervicales et thoraciques ne seraient pas supérieures à un contact manuel placebo(Bautista-Aguirre et al., 2017). Les manipulations ne semblent donc pas le traitement le plus adapté pour améliorer les symptômes de ce type.Les exercices cervicaux et les manipulations thoraciques supérieures permettent tous deux une diminution de la douleur ainsi qu'une amélioration de la proprioception. ...
Design de l’étude : Revue systématique (SR) But de l’étude : Réaliser une mise à jour de la littérature à propos de l’effet de la thérapie manuelle appliquée au thorax sur les douleurs de nuque. Matériel et méthode : Une recherche de la littérature a été réalisée sur 4 différents moteurs de recherche à savoir Pubmed, Cochrane, Scopus et Sciences Direct en avril 2017. Seules les études randomisées contrôlées (RCT), publiées à partir de janvier 2013 jusqu’avril 2017, évaluant l’efficacité de la thérapie manuelle thoracique sur des patients âgés entre 18 et 70 ans ont été inclus dans la SR. La qualité de ces études a été évaluée par le score PEDRO mais également via l’effect size. Résultats : 15 RCT ont finalement été retenues. La qualité des études varie entre 6 et 10 points sur le score Pedro. Aucune nouvelle évidence sur les douleurs de nuque aiguë ou subaiguë n’a pu être trouvée par manque de littérature. Les études concernant les douleurs chroniques ont permis d’appuyer l’efficacité de la TM appliqué au thorax. Pour les douleurs non spécifiques, les manipulations permettent d’améliorer la douleur, l’amplitude et la fonction des sujets. Elles semblent supérieures aux mobilisations sur le thorax. En ce qui concerne les radiculopathies, la seule nouvelle évidence apportée est l’efficacité des Transverse oscillatory pressure (TOP) pour diminuer la douleur. Enfin, pour les céphalées cervicogéniques, la TM est efficace lorsque les manipulations thoraciques et cervicales sont combinées. Conclusion : Les évidences précédentes sont confirmées, voir augmentées, à savoir que la thérapie manuelle au niveau thoracique permettrait de diminuer la douleur, améliorer l’amplitude cervicale ainsi que la fonction chez les patients cervicalgiques. L’efficacité de la thérapie manuelle varie toutefois en fonction des techniques appliquées, ainsi que du type de cervicalgies.
Référence bibliographique Lebrun, Laurie ; Vandamme, Delphine. Update de la littérature des effets de la thérapie manuelle thoracique sur les cervicalgies : revue systématique. Faculté des sciences de la motricité, Université catholique de Louvain, 2017. Prom. : Hidalgo, Benjamin.
Permalien http://hdl.handle.net/2078.1/thesis:8860
... [10,13,14,[20][21][22] However, the evidence for its effectiveness and clinical usefulness have been lacking until recently [8,11]. Previous research has been either efficacy studies or designed with little consideration of how MC is delivered in clinical practice [23][24][25][26]. ...
Background
Chiropractic maintenance care is effective as secondary/tertiary prevention of non-specific low back pain (LBP), but the potential effect moderation by psychological characteristics is unknown. The objective was to investigate whether patients in specific psychological sub-groups had different responses to MC with regard to the total number of days with bothersome pain and the number of treatments.
Method
Data from a two-arm randomized pragmatic multicenter trial with a 12-month follow up, designed to investigate the effectiveness of maintenance care, was used. Consecutive patients, 18–65 years of age, with recurrent and persistent LBP seeking chiropractic care with a good effect of the initial treatment were included. Eligible subjects were randomized to either maintenance care (prescheduled care) or to the control intervention, symptom-guided care. The primary outcome of the trial was the total number of days with bothersome LBP collected weekly for 12 months using an automated SMS system. Data used to classify patients according to psychological subgroups defined by the West Haven-Yale Multidimensional Pain Inventory (adaptive copers, interpersonally distressed and dysfunctional) were collected at the screening visit.
Results
A total of 252 subjects were analyzed using a generalized estimating equations linear regression framework. Patients in the dysfunctional subgroup who received maintenance care reported fewer days with pain (-30.0; 95% CI: -36.6, -23.4) and equal number of treatments compared to the control intervention. In the adaptive coper subgroup, patients who received maintenance care reported more days with pain (10.7; 95% CI: 4.0, 17.5) and more treatments (3.9; 95% CI: 3.5, 4.2). Patients in the interpersonally distressed subgroup reported equal number of days with pain (-0.3; 95% CI: -8.7, 8.1) and more treatments (1.5; 95% CI: 0.9, 2.1) on maintenance care.
Conclusions
Psychological and behavioral characteristics modify the effect of MC and should be considered when recommending long-term preventive management of patients with recurrent and persistent LBP.
... Numerous studies have demonstrated significant differences in favor of combining techniques in comparison with performing them independently or with respect to medical interventions based on pharmacology [51][52][53][54][55][56][57][58]. In addition, strong scientific evidence shows that the biobehavioral approach is effective in patients with CLBP [59]; also, research studies in other chronic pain conditions have demonstrated the effectiveness of this approach in combination with the therapeutic exercise in terms of physical and psychological variables [22,57,60,61]. ...
Objective:
To compare the effectiveness of a biobehavioral approach with and without orthopedic manual physical therapy on the intensity and frequency of pain in patients diagnosed with nonspecific chronic low back pain.
Methods:
A single-blind randomized controlled trial. Fifty patients were randomly allocated into two groups: one group received biobehavioral therapy with orthopedic manual physical therapy, and the other group received only biobehavioral therapy. Both groups completed a total of eight sessions, with a frequency of two sessions per week. The somatosensory, physical, and psychological variables were recorded at baseline and during the first and third month after initiation of treatment.
Results:
In both groups, the treatment was effective, presenting significant differences for all the variables in the time factor. There were no significant differences between groups in intensity or frequency of pain, with a large effect size (>0.80), but there were intragroup differences for both intervention groups at one- and three-month follow-up. There were also no significant differences between groups in the secondary variables during the same follow-up period.
Conclusions:
The results of this study suggest that orthopedic manual physical therapy does not increase the effects of a treatment based on biobehavioral therapy in the short or medium term, but these results should be interpreted with caution.
... However, the study indicated that nine to 12 of chiropractic care treatments are needed for the treatment of cervicogenic headache. blinded placebo controlled RCT assessing the effectiveness of spinal manipulation therapy (SMT) in chronic nonspecific LBP was published [9]. The study concluded that 12 SMT treatments in a one month period is effective in the treatment of chronic nonspecific LPB. ...
... We may speculate that the central modulation of pain concomitant with mechanical local and/or regional factors [79] may have influenced the response to treatment in both groups. It should however be taken into account that several studies shown similar shortterm pain response [76,77,[80][81][82][83][84]. ...
Background: Empathy plays a role in medical care. Studies have showed that higher empathy levels of physicians correlates with better patient outcomes. The role of empathy in osteopathic practice has been poorly investigated. Objective: To explore the feasibility of analysing the link between the empathy of osteopaths and the improvement in persistent musculoskeletal pain patients. Participants: 13 trainees attending the 5th year in a reference osteopathic teaching institution and 39 patients with chronic musculoskeletal pain. Methods: Trainees were tested for their empathy level by using the Jefferson Scale of Physician Empathy-Health Professional. Trainees with a score higher than the 80 th percentile and lower than the 20 th percentiles were identified as “highly” and “poorly” empathic therapists and were assigned respectively to the HET and LET group. Each trainee was assigned to patients. Pain intensity was monitored throughout the study by the validated Numerical Rating Scale (NRS). Results: Patients included into the HET and LET groups had comparable baseline characteristics. Both groups benefited from the treatment. The mean NRS improvement score in the HET group was 6.4 (95% CI 5.3 to 7.5; p < 0.0001). The LET mean NRS improvement score was 3.5 (95% CI 2.1 to 4.8; p < 0.0001). The intergroup difference indicated that the two patient groups differed in pain intensity starting from the third treatment (T3 p = 0.0032 and T4 p = 0.0021). Conclusions: Research on the link between empathy of therapists and the outcome of Osteopathic Manipulative Treatment for chronic musculoskeletal pain appears feasible. The reported findings might help to design further confirmatory studies.
... The results of this study support the findings of the only other sufficiently powered RCT, by Senna and Shereen, to have investigated preventive manual care [36]. They found that patients who continued to receive spinal manipulation after an initial course of care had lower pain and disability scores at a 10-month follow-up. ...
Background
For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.
Method
This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.
Results
Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.
Conclusion
MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.
... Of the 25 unimodal RCT studies , 3 (12%) were given a SIGN 50 score of high quality (++) [32][33][34], 18 (72%) as acceptable quality (+) [35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52], and 4 (16%) as low quality (0) [53][54][55][56]. Among the 26 multimodal studies, 3 (12%) were rated high quality (++) [88][89][90], 20 (77%) acceptable quality (+) [68][69][70][71][72][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87]94], and 3 (11%) low quality (0) [64,65,67,96]. The most prevalent poorly addressed quality criteria related to pitfalls in reporting group differences, intention-to-treat analyses, and multisite similarities, respectively. ...
Background context:
Mobilization and manipulation therapies are widely used to benefit patients with chronic low back pain. However, questions remain about their efficacy, dosing, safety, as well as how these approaches compare to other therapies.
Purpose:
To determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic low back pain.
Study design/setting:
A systematic literature review and meta-analysis.
Outcome measures:
Self-reported pain, function, health-related quality of life, adverse events.
Methods:
We identified studies by searching multiple electronic databases from January 2000 to March 2017, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation and/or mobilization therapies to sham, no treatment, other active therapies, and multimodal therapeutic approaches. We assessed risk of bias using Scottish Intercollegiate Guidelines Network criteria. Where possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was applied to determine the confidence in effect estimates. This project is funded by the National Center for Complementary and Integrative Health under Award Number U19AT007912.
Results:
51 trials were included in the systematic review. Nine trials (1176 patients) provided sufficient data and were judged similar enough to be pooled for meta-analysis. The standardized mean difference for a reduction of pain was SMD= -0.28, 95% CI, -0.47 to -0.09, P=0.004; I2=57% at post-treatment; within seven trials (923 patients) the reduction in disability was SMD= -0.33, 95% CI, -0.63 to -0.03, P=0.03; I2=78% for manipulation or mobilization as compared to other active therapies. Subgroup analyses showed that manipulation significantly reduced pain and disability, compared to other active comparators including exercise and physical therapy (SMD= -0.43, 95% CI, -0.86 to 0.00; P=0.05, I2=79%), (SMD= -0.86, 95% CI, -1.27 to -0.45; P<0.0001, I2=46%). Mobilization interventions, as compared to other active comparators including exercise regimens, significantly reduced pain (SMD= -0.20, 95% CI, -0.35 to -0.04; p=0.01; I2=0%) but not disability (SMD= -0.10, 95% CI, -0.28 to 0.07; p=0.25; I2=21%). Studies comparing manipulation or mobilization to sham or no treatment were too few or too heterogeneous to allow for pooling as were studies examining relationships between dose and outcomes. Few studies assessed health-related quality of life. Twenty-six of the 51 trials were multimodal studies and narratively described.
Conclusions:
There is moderate-quality evidence that manipulation and mobilization are likely to reduce pain and improve function for patients with chronic low back pain; manipulation appears to produce a larger effect than mobilization. Both therapies appear safe. Multimodal programs may be a promising option.
... Fleig, Pomp, Schwarzer, and Lippke (2013) found the addition of two booster sessions to a self-management exercise intervention improved selfefficacy, satisfaction, exercise, and habit strength. While booster sessions have been proposed by others (Descarreaux et al., 2004;Senna and Machaly, 2011), research investigating the effectiveness of this approach for LBP is still scarce. A trial conducted by Tavafian, Jamshidi and Mohammad (2011) has found reduced pain and disability when a multidisciplinary program of monthly telephone motivation and booster classes plus oral medication was used in patients with CLBP. ...
Background:
Improvements in chronic low back pain (CLBP) seen in physical therapy do not appear to be retained over the long term. Booster sessions have been proposed, but barriers exist to their implementation. Telerehabilitation (TR) and remote patient monitoring (RPM) may be ways to circumvent these barriers. The purpose of this case series was to describe the implementation of TR booster sessions and RPM in three patients with CLBP.
Case series:
Three females with CLBP tracked their daily pain level and home exercise program adherence using a mobile phone application for 12 months following discharge from traditional face-to-face physical therapy. Synchronous audio and video TR booster sessions were conducted at months 1, 3, 6, and 12.
Outcomes:
All patients met their individual goals. They demonstrated excellent home exercise program adherence and self-efficacy. A temporary increase in pain was seen in all patients, but they managed solely with the TR booster sessions and without other healthcare resources. Satisfaction with the program was very high.
Conclusions:
This case series describes the use of TR booster sessions and RPM in three patients with CLBP. The positive results suggest this approach may be helpful in improving long-term management of patients with CLBP but demand further investigation.
... Long term management may aid in maintaining the improvement in functional capacity achieved during a short course of treatment [25] and may minimize the impact of future exacerbations [26]. This theory is supported by a small study showing that nine months of continued treatment with SMT sustained participants' improvement in low back pain and disability compared to those receiving only one month of SMT [27]; however, the effectiveness of long term management of back and neck disability in older adults has yet to be investigated in a full scale trial [28]. ...
Background
Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of future exacerbations. Research is limited comparing short courses of treatment to long term management of spinal disability.
The primary aim is to compare the relative effectiveness of 12 weeks versus 36 weeks of SMT and supervised rehabilitative exercise (SRE) in older adults with back and neck disability.
Methods/Design
Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area.
Participants
Independently ambulatory community dwelling adults ≥ 65 years of age with back and neck disability of minimum 12 weeks duration (n = 200).
Interventions
12 weeks SMT + SRE or 36 weeks SMT + SRE.
Randomization
Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes.
Blinding
Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment.
Primary endpoint
36 weeks post-randomization.
Data collection
Self-report questionnaires administered at 2 baseline visits and 4, 12, 24, 36, 52, and 78 weeks post-randomization. Primary outcomes include back and neck disability, measured by the Oswestry Disability Index and Neck Disability Index. Secondary outcomes include pain, general health status, improvement, self-efficacy, kinesiophobia, satisfaction, and medication use. Functional outcome assessment occurs at baseline and week 37 for hand grip strength, short physical performance battery, and accelerometry. Individual qualitative interviews are conducted when treatment ends. Data on expectations, falls, side effects, and adverse events are systematically collected.
Primary analysis
Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates.
Discussion
Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy.
Trial registry
www.ClinicalTrials.gov; Identifier: NCT01057706.
Keywords
Neck disability Back disability Spinal manipulative therapy Exercise therapy Older adults Mixed-methods Comparative effectiveness
... Low-quality evidence showed no difference in pain with spinal manipulation versus sham manipulation at 1 month (134,135). Low-quality evidence showed that spinal manipulation slightly improved pain compared with an inert treatment (136 -142). Moderate-quality evidence showed no clear differences in pain or function compared with another active intervention. ...
Description:
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain.
Methods:
Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and nonpharmacologic treatments for low back pain. Updated searches were performed through November 2016. Clinical outcomes evaluated included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability and return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects.
Target audience and patient population:
The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute, subacute, or chronic low back pain.
Recommendation 1:
Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation).
Recommendation 2:
For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation).
Recommendation 3:
In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence).
... Trial characteristics are detailed in Table 1. Of the 25 included studies, 16 of the trials were specifically assessing LP-SMT [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. There were three trials where subjects in the active treatment group could also receive thrust manipulation to joints other than those in the lumbar spine and pelvis [32][33][34], and two trials that were assessing LP-SMT and medications [35,36]. ...
Background context:
Spinal manipulative therapy (SMT) has been attributed with substantial non-specific effects. Accurate assessment of the non-specific effects of SMT relies on high-quality studies with low risk of bias that compare with appropriate placebos.
Purpose:
This review aims to characterize the types and qualities of placebo control procedures used in controlled trials of manually applied, lumbar and pelvic (LP)-SMT, and to evaluate the assessment of subject blinding and expectations.
Study design:
This is a systematic review of randomized, placebo-controlled trials.
Methods:
We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Index to Chiropractic Literature, and relevant bibliographies. We included randomized, placebo or sham-controlled trials where the index treatment was manually applied LP-SMT. There were no restrictions on the type of condition being investigated. Two independent reviewers selected the studies, assessed study quality, and extracted the data. Relevant data were the type and quality of placebo control(s) used, the assessment of blinding and expectations, and the results of those assessments.
Results:
Twenty-five randomized, placebo-controlled trials were included in this review. There were 18 trials that used a sham manual SMT procedure for their placebo control intervention; the most common approach was with an SMT setup but without the application of any thrust. One small pilot study used an unequivocally indistinguishable placebo, two trials used placebos that had been validated as inert a priori, and eight trials reported on the success of subject blinding. Risk of bias was high or unclear, for all included studies.
Conclusions:
Imperfect placebos are ubiquitous in clinical trials of LP-SMT, and few trials have assessed for successful subject blinding or balanced expectations of treatment success between active and control group subjects. There is thus a strong potential for unmasking of control subjects, unequal non-specific effects between active and control groups, and non-inert placebos in existing trials. Future trials should consider assessing the success of subject blinding and ensuring inertness of their placebo a priori, as a minimum standard for quality.
... Frequently, studies investigating chiropractic and lower back pain specifically exclude patients with a history of spinal surgery. [110][111][112][113] Large-scale randomized controlled trials are needed to effectively assess the safety and efficacy of chiropractic care for patients after lumbar fusion. Clinical trials are needed to assess the risk-to-benefit ratio of various chiropractic modalities for lumbar fusion. ...
Objective:
The purpose of this narrative review was to describe the most common spinal fusion surgical procedures, address the clinical indications for lumbar fusion in degeneration cases, identify potential complications, and discuss their relevance to chiropractic management of patients after surgical fusion.
Methods:
The PubMed database was searched from the beginning of the record through March 31, 2015, for English language articles related to lumbar fusion or arthrodesis or both and their incidence, procedures, complications, and postoperative chiropractic cases. Articles were retrieved and evaluated for relevance. The bibliographies of selected articles were also reviewed.
Results:
The most typical lumbar fusion procedures are posterior lumbar interbody fusion, anterior lumbar interbody fusion, transforaminal interbody fusion, and lateral lumbar interbody fusion. Fair level evidence supports lumbar fusion procedures for degenerative spondylolisthesis with instability and for intractable low back pain that has failed conservative care. Complications and development of chronic pain after surgery is common, and these patients frequently present to chiropractic physicians. Several reports describe the potential benefit of chiropractic management with spinal manipulation, flexion-distraction manipulation, and manipulation under anesthesia for postfusion low back pain. There are no published experimental studies related specifically to chiropractic care of postfusion low back pain.
Conclusions:
This article describes the indications for fusion, common surgical practice, potential complications, and relevant published chiropractic literature. This review includes 10 cases that showed positive benefits from chiropractic manipulation, flexion-distraction, and/or manipulation under anesthesia for postfusion lumbar pain. Chiropractic care may have a role in helping patients in pain who have undergone lumbar fusion surgery.
Objective
The purpose of this study was to determine whether chiropractic clinicians modulate spinal manipulation (SM) thrust characteristics based on visual perception of simulated human silhouette attributes.
Methods
We performed a cross-sectional within-participant design with 8 experienced chiropractors. During each trial, participants observed a human-shaped life-sized silhouette of a mock patient and delivered an SM thrust on a low-fidelity thoracic spine model based on their visual perception. Silhouettes varied on the following 3 factors: apparent sex (male or female silhouette), height (short, average, tall), and body mass index (BMI) (underweight, healthy, obese). Each combination was presented 6 times for a total of 108 trials in random order. Outcome measures included peak thrust force, thrust duration, peak preload force, peak acceleration, time to peak acceleration, and rate of force application. A 3-way repeated measures analysis of variance model was used to for each variable, followed by Tukey's honestly significant difference on significant interactions.
Results
Peak thrust force was reduced when apparent sex of the presented silhouette was female (F1,7 = 5.70, P = .048). Thrust duration was largely invariant, except that a BMI by height interaction revealed a longer duration occurred for healthy tall participants than healthy short participants (F4,28 = 4.34, P = .007). Compared to an image depicting obese BMI, an image appearing underweight lead to reduced peak acceleration (F2,5 = 6.756, P = .009). Clinician time to peak acceleration was reduced in short compared to tall silhouettes (t7 = 2.20, P = .032).
Conclusion
Visual perception of simulated human silhouette attributes, including apparent sex, height, and BMI, influenced SM dose characteristics through both kinetic and kinematic measures. The results suggest that visual information from mock patients affects the decision-making of chiropractic clinicians delivering SM thrusts.
Objective:
To evaluate the existing body of trials assessing manual therapy for low back pain (LBP) to determine where it falls on the efficacy-effectiveness continuum.
Design:
Methodology systematic review.
Literature search:
PubMed, CINAHL, CENTRAL, and PEDro were searched for trials published between January 1, 2000, and April 30, 2021.
Study selection criteria:
We included randomized clinical trials investigating joint mobilization and manipulation for adults with non-specific LBP that were available in English.
Data synthesis:
We used the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool to score included trials across 4 domains: Participant Characteristics, Trial Setting, Flexibility of Intervention(s), and Clinical Relevance of Experimental and Comparison Intervention(s). Proportions of trials with greater emphasis on efficacy or effectiveness were calculated for each domain.
Results:
Of 132 included trials, a greater proportion emphasized efficacy than effectiveness for the domains of Participant Characteristics (50% vs 38%), Trial Setting (71% vs 20%), and Flexibility of Intervention(s) (61% vs 25%). The domain Clinical Relevance of Experimental and Comparison Intervention(s) had a lower emphasis on efficacy (41% vs 50%).
Conclusions:
Most trials investigating manual therapy for LBP lack pragmatism across the RITES domains (i.e., they emphasize efficacy). To improve real-world implementation, more research emphasizing effectiveness is needed. This could be accomplished by recruiting from more diverse participant pools, involving multiple centers that reflect common clinical practice settings, involving clinicians with a variety of backgrounds/experience, and allowing flexibility in how interventions are delivered.
Importance
Osteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations.
Objective
To compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP.
Design, Setting, and Participants
This prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial recruited participants with nonspecific subacute or chronic LBP from a tertiary care center in France starting February 17, 2014, with follow-up completed on October 23, 2017. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 22, 2018, to December 5, 2018.
Interventions
Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by nonphysician, nonphysiotherapist osteopathic practitioners.
Main Outcomes and Measures
The primary end point was mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100). Secondary outcomes were mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leaves, as well as number of LBP episodes at 12 months; and consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.
Results
Overall, 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode was 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months. The mean (SD) Quebec Back Pain Disability Index scores for the standard OMT group were 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months, and in the sham OMT group were 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months. The mean reduction in LBP-specific activity limitations at 3 months was −4.7 (95% CI, −6.6 to −2.8) and −1.3 (95% CI, −3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, −3.4; 95% CI, −6.0 to −0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was −4.3 (95% CI, −7.6 to −1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was −1.0 (95% CI, −5.5 to 3.5; P = .66) and −2.0 (95% CI, −7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.
Conclusions and Relevance
In this randomized clinical trial of patients with nonspecific subacute or chronic LBP, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.
Trial Registration
ClinicalTrials.gov Identifier: NCT02034864
OBJECTIVES
To assess the effectiveness of lumbar manipulation (high velocity low amplitude)for the treatment of low back pain in comparison to back stretching exercises.Randomized Control Trial (Experimental Study)The study was conducted on 200 patients at the Physiotherapy Department ofZiauddin Hospital among patients with history of low back pain of acute, subacute or chronic origin. In this study, patients were divided into two groups,group A and group B equally. Group A of 100 patients received Lumbar Manipulation(High Velocity Low Amplitude) and at the same time Group B of 100patients were treated by back stretching exercises. A pre tested and structuredquestionnaire was used to collect data. Data was entered and analyzed byusing SPSS.Pain was measured on Visual Analogue Scale before and after the giventreatment.The study showed significant results for both the interventions in the treatment oflow back pain but Lumbar Manipulation has been more effective in differenttypes of low back pain while stretching exercises are less effective.On the basis of this study, we are very confident that lumbar manipulation ismore effective for the treatment of low back pain compared to back stretching
Objective: To estimate the extent to which spinal manipulation is effective for adult patients with chronic non-specific low back pain (CNSLBP) Design: Systematic review and meta-analysis of randomized controlled trials. Data sources: Ovid Medline, Ovid AMED, Ovid EMBASE, CINAHL, Index to Chiropractic Literature (ICL); Cochrane Library, PubMed, and Trip database. Eligibility criteria for selecting studies: Randomized controlled trials examining the effect of spinal manipulation therapy (SMT) in adults (≥ 18 years) with chronic non-specific low back pain. Review methods: Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardized mean differences (SMD), respectively. Outcomes were examined at 6, 12, 18, 24 weeks and one year. Quality of evidence was assessed using GRADE. Risk of bias, statistical heterogeneity and precision was explored. Results: Nine randomized controlled trials including a total of 1777 participants were identified, who were on average middle aged (18-65 years). The trials had considerable percentages of risk of bias. Moderate quality evidence suggested that the pooled estimate of pain intensity after one year and functional disability after 6 weeks of SMT is significantly effective (MD=-9.88, CI=-16.51,-3.24) and (MD=-7.59, CI=-8.47,-6.71) respectively. Regarding pain intensity, no statistically significant difference was recorded between experimental and control groups at 6 and 24 weeks after SMT (MD=1.16, CI=-15.25, 17.56, MD=-5.12, CI=-12.86, 2.63 respectively). Regarding functional disability, no significant difference was recorded between both groups at 18 and 24 weeks after SMT (MD=-4.05, CI=-18.47, 10.37, MD=-3.90, CI=-14.60, 6.80 respectively). Also, no significant difference was detected between both studied groups regarding physical and mental health at 12 weeks, 24 weeks and 1 year of SMT and mean satisfaction with SMT. Conclusion: It is difficult from the included studies to conclude that spinal manipulation is superior to conventional treatment for CNSLBP in short term effect but adding spinal manipulation with other conventional therapies may be beneficial for long-term benefit. However, given the small number of studies included in this analysis, we should be cautious of making strong inferences based on these results. The research to date is still heterogeneous, and questions remain about optimal treatment duration, number of sessions, practitioners to be involved, and the kinds of patients who may benefit the most.
Objective: To estimate the extent to which spinal manipulation is effective for adult patients with chronic non-specific low back pain (CNSLBP) Design: Systematic review and meta-analysis of randomized controlled trials. Data sources: Ovid Medline, Ovid AMED, Ovid EMBASE, CINAHL, Index to Chiropractic Literature (ICL); Cochrane Library, PubMed, and Trip database. Eligibility criteria for selecting studies: Randomized controlled trials examining the effect of spinal manipulation therapy (SMT) in adults (≥ 18 years) with chronic non-specific low back pain. Review methods: Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardized mean differences (SMD), respectively. Outcomes were examined at 6, 12, 18, 24 weeks and one year. Quality of evidence was assessed using GRADE. Risk of bias, statistical heterogeneity and precision was explored. Results: Nine randomized controlled trials including a total of 1777 participants were identified, who were on average middle aged (18-65 years). The trials had considerable percentages of risk of bias. Moderate quality evidence suggested that the pooled estimate of pain intensity after one year and functional disability after 6 weeks of SMT is significantly effective (MD=-9.88, CI=-16.51,-3.24) and (MD=-7.59, CI=-8.47,-6.71) respectively. Regarding pain intensity, no statistically significant difference was recorded between experimental and control groups at 6 and 24 weeks after SMT (MD=1.16, CI=-15.25, 17.56, MD=-5.12, CI=-12.86, 2.63 respectively). Regarding functional disability, no significant difference was recorded between both groups at 18 and 24 weeks after SMT (MD=-4.05, CI=-18.47, 10.37, MD=-3.90, CI=-14.60, 6.80 respectively). Also, no significant difference was detected between both studied groups regarding physical and mental health at 12 weeks, 24 weeks and 1 year of SMT and mean satisfaction with SMT. Conclusion: It is difficult from the included studies to conclude that spinal manipulation is superior to conventional treatment for CNSLBP in short term effect but adding spinal manipulation with other conventional therapies may be beneficial for long-term benefit. However, given the small number of studies included in this analysis, we should be cautious of making strong inferences based on these results. The research to date is still heterogeneous, and questions remain about optimal treatment duration, number of sessions, practitioners to be involved, and the kinds of patients who may benefit the most.
The objective of this study was to catalogue items from instruments used to measure functioning, disability, and contextual factors in patients with low back pain (LBP) treated with manual medicine (manipulation and mobilization) according to the International Classification of Functioning, Disability and Health (ICF). This catalogue will be used to inform the development of an ICF-based assessment schedule for LBP patients treated with manual medicine. In this scoping review we systematically searched MEDLINE, Embase, PsycINFO and CINAHL. We identified instruments (questionnaires, clinical tests, single questions) used to measure functioning, disability and contextual factors, extracted the relevant items and then linked these items to the ICF. We included 95 articles and identified 1510 meaningful concepts. All but 70 items were linked to the ICF. Of the concepts linked to the ICF, body functions accounted for 34.7%, body structures accounted for 0%, activities and participation accounted for 41%, environmental factors accounted for 3.6%, and personal factors accounted for 16%. Most items used to measure functioning and disability in LBP patient treated with manual medicine focus on body functions, and activities and participation. The lack of measures that address environmental factors warrants further investigation.
Objective:
To investigate the effectiveness of spinal manipulation combined with myofascial release compared with spinal manipulation alone, in individuals with chronic non-specific low back pain (CNLBP).
Design:
Randomized controlled trial with three months follow-up.
Setting:
Rehabilitation clinic.
Participants:
Seventy-two individuals (between 18 and 50 years of age; CNLBP ≥12 consecutive weeks) were enrolled and randomly allocated to one of two groups: (1) Spinal manipulation and myofascial release - SMMRG; n=36) or (2) Spinal manipulation alone (SMG; n=36).
Interventions:
Combined spinal manipulation (characterized by high velocity/low amplitude thrusts) of the sacroiliac and lumbar spine and myofascial release of lumbar and sacroiliac muscles vs manipulation of the sacroiliac and lumbar spine alone, twice a week, for three weeks.
Main outcome measures:
Assessments were performed at baseline, three weeks post intervention and three months follow-up. Primary outcomes were pain intensity and disability. Secondary outcomes were quality of life, pressure pain-threshold and dynamic balance.
Results:
No significant differences were found between SMMRG vs SMG in pain intensity and disability post intervention and at follow-up. We found an overall significant difference between-groups for CNLBP disability (SMG-SMMRG: mean difference of 5.0; 95% confidence interval of difference 9.9; -0.1), though this effect was not clinically important and was not sustained at follow-up.
Conclusions:
We demonstrated that spinal manipulation combined with myofascial release was not more effective compared to spinal manipulation alone for patients with CNLBP.
Clinical trial registration number:
NCT03113292.
Objective:
To investigate trials abstracts evaluating treatments for low back pain with regards to completeness of reporting, spin (i.e., interpretation of study results that overemphasizes the beneficial effects of the intervention), and inconsistencies in data with the full text.
Data sources:
The search was performed on Physiotherapy Evidence Database (PEDro) in February 2016.
Study selection:
This is an overview study of a random sample of 200 low back pain trials published between 2010 and 2015. The languages of publication were restricted to English, Spanish and Portuguese.
Data extraction:
Completeness of reporting was assessed using the CONSORT for Abstracts checklist (CONSORT-A). Spin was assessed using a SPIN-checklist. Consistency between abstract and full text were assessed by applying the assessment tools to both the abstract and full text of each trial and calculating inconsistencies in the summary score (paired t test) and agreement in the classification of each item (Kappa statistics). Methodological quality was analyzed using the total PEDro score.
Data synthesis:
The mean number of fully reported items for abstracts using the CONSORT-A was 5.1 (SD 2.4) out of 15 points and the mean number of items with spin was 4.9 (SD 2.6) out of 7 points. Abstract and full text scores were statistically inconsistent (P=0.01). There was slight to moderate agreement between items of the CONSORT-A in the abstracts and full text (mean Kappa 0.20 SD 0.13) and fair to moderate agreement for items of the SPIN-checklist (mean Kappa 0.47 SD 0.09).
Conclusions:
The abstracts were incomplete, with spin and inconsistent with the full text. We advise health care professionals to avoid making clinical decisions based solely upon abstracts. Journal editors, reviewers and authors are jointly responsible for improving abstracts, which could be guided by amended editorial policies.
Objective
To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain.
Design
Systematic review and meta-analysis of randomised controlled trials.
Data sources
Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews.
Eligibility criteria for selecting studies
Randomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting.
Review methods
Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored.
Results
47 randomised controlled trials including a total of 9211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference −3.17, 95% confidence interval −7.85 to 1.51) and a small, clinically better improvement in function (SMD −0.25, 95% confidence interval −0.41 to −0.09). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference −7.48, −11.50 to −3.47) and small to moderate clinically better improvement in function (SMD −0.41, −0.67 to −0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.
Conclusion
SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
Objective
Back and neck pain are associated with disability and loss of independence in older adults. It's unknown whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Methods
Eligible participants were age 65 and older with back and neck disability for more than 12 weeks. Co‐primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed‐model analysis to detect between group differences. Secondary analyses included other self‐reported outcomes, adverse events and objective functional measures.
Results
182 participants were randomized. The short‐term and long‐term groups demonstrated significant improvements in back (‐3.9, 95% confidence interval (CI) ‐5.8 to ‐2.0 versus ‐6.3, 95% CI ‐8.2 to ‐4.4) and neck disability (‐7.3, 95% CI ‐9.1 to ‐5.5 versus ‐9.0, 95% CI = ‐10.8 to ‐7.2) after 36 weeks, with no difference between groups (back 2.4, 95% CI ‐0.3 to 5.1; neck 1.7, 95% CI ‐0.8 to 4.2). The long‐term management group experienced greater improvement in neck pain at week 36, self‐efficacy at week 36 and 52, functional ability and balance.
Conclusion
For older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.
This article is protected by copyright. All rights reserved.
Objective:
Scientific literature applicable to chiropractic practice proliferates in quantity, quality, and source. Chiropractic is a worldwide profession and varies in scope between states or provinces and from country to country. It is logical to consider that the focus and emphasis of chiropractic education varies between programs as well. This original research study endeavored to determine "essential literature" recommended by chiropractic faculty. The purpose of this article is (1) to share our results and (2) to promote discussion and explore means for future collaboration of chiropractic faculty through a worldwide platform.
Methods:
A 2-phase recruitment occurred initially at the institutional level and subsequently at the faculty level. A Web-based survey used qualitative data collection methods to gather bibliographic citations. Descriptive statistics were calculated for demographics, and citation responses were ranked per number of recommendations, grouped into categories, and tabulated per journal source and publication date.
Results:
Forty-one chiropractic programs were contacted, resulting in 30 participating chiropractic programs (16 US and 14 international). Forty-five faculty members completed the entire survey, submitting 126 peer-reviewed publications and 25 additional citations. Readings emphasized clinical management of spine pain, the science of spinal manipulation, effectiveness of manual therapies, teaching of chiropractic techniques, outcomes assessments, and professional issues.
Conclusion:
A systematic approach to surveying educators in international chiropractic institutions was accomplished. The results of the survey provide a list of essential literature for the chiropractic profession. We recommend establishing a chiropractic faculty registry for improved communication and collaboration.
Viele Patienten mit Schmerzen im Bewegungssystem suchen einen Manualmediziner, Osteopathen oder Chiropraktiker auf. Diese behandeln jedoch nicht Schmerzen, sondern Funktionsstörungen des Bewegungssystems, wie z. B. Triggerpunkte oder Blockierungen. Bei akuten Schmerzen sind diese Behandlungen oft erfolgreich und auch bei chronischen Schmerzen kann die manuelle Medizin einen wichtigen Beitrag in Diagnostik und Therapie leisten. Auf der anderen Seite hat sich in den letzten Jahren ein neues Fachgebiet, die spezielle Schmerztherapie entwickelt. Insbesondere chronische Schmerzen stellen hier ein eigenständiges Krankheitsbild ohne Einfluss von körperlichen Befunden dar (als Schmerzchronifizierung). In dem Spannungsfeld zwischen (schmerzhaftem) Befund und Schmerzchronifizierung bewegen sich Patienten und Therapeuten und müssen in der Praxis die patientenindividuelle Konstellation täglich neu erarbeiten.
While spinal manipulative therapy (SMT) is recommended for the treatment of spinal disorders, concerns exist about adverse events associated with the intervention. Adequate reporting of adverse events in clinical trials would allow for more accurate estimations of incidence statistics through meta-analysis. However, it is not currently known if there are factors influencing adverse events reporting following SMT in randomized clinical trials (RCTs). Thus our objective was to investigate predictive factors for the reporting of adverse events in published RCTs involving SMT. The Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included: sample size; publication date relative to the 2010 CONSORT statement; risk of bias; the region treated; and number of intervention sessions. 7398 records were identified, of which 368 articles were eligible for inclusion. A total of 140 (38.0%) articles reported on adverse events. Articles were more likely to report on adverse events if they: possessed larger sample sizes, were published after the 2010 CONSORT statement, had a low risk of bias and involved multiple intervention sessions. The region treated was not a significant predictor for reporting on adverse events. Predictors for reporting on adverse events included: larger sample size, publication after the 2010 CONSORT statement, low risk of bias and trials involving multiple intervention sessions. We recommend that researchers focus on developing robust methodologies and participant follow-up regimens for RCTs involving SMT.
Background:
A 2007 American College of Physicians guideline addressed nonpharmacologic treatment options for low back pain. New evidence is now available.
Purpose:
To systematically review the current evidence on nonpharmacologic therapies for acute or chronic nonradicular or radicular low back pain.
Data sources:
Ovid MEDLINE (January 2008 through February 2016), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and reference lists.
Study selection:
Randomized trials of 9 nonpharmacologic options versus sham treatment, wait list, or usual care, or of 1 nonpharmacologic option versus another.
Data extraction:
One investigator abstracted data, and a second checked abstractions for accuracy; 2 investigators independently assessed study quality.
Data synthesis:
The number of trials evaluating nonpharmacologic therapies ranged from 2 (tai chi) to 121 (exercise). New evidence indicates that tai chi (strength of evidence [SOE], low) and mindfulness-based stress reduction (SOE, moderate) are effective for chronic low back pain and strengthens previous findings regarding the effectiveness of yoga (SOE, moderate). Evidence continues to support the effectiveness of exercise, psychological therapies, multidisciplinary rehabilitation, spinal manipulation, massage, and acupuncture for chronic low back pain (SOE, low to moderate). Limited evidence shows that acupuncture is modestly effective for acute low back pain (SOE, low). The magnitude of pain benefits was small to moderate and generally short term; effects on function generally were smaller than effects on pain.
Limitation:
Qualitatively synthesized new trials with prior meta-analyses, restricted to English-language studies; heterogeneity in treatment techniques; and inability to exclude placebo effects.
Conclusion:
Several nonpharmacologic therapies for primarily chronic low back pain are associated with small to moderate, usually short-term effects on pain; findings include new evidence on mind-body interventions.
Primary funding source:
Agency for Healthcare Research and Quality. (PROSPERO: CRD42014014735).
Characteristics of included trials.
A table showing the characteristics of included trials and their references.
(PDF)
Study Design. A systematic review of randomized controlled trials. Objectives. To assess the effectiveness of the most common conservative types of treatment for patients with acute and chronic nonspecific low back pain. Summary of Background Data. Many treatment options for acute and chronic low back pain are available, but little is known about the optimal treatment strategy. Methods. A rating system was used to assess the strength of the evidence, based on the methodologic quality of the randomized controlled trials, the relevance of the outcome measures, and the consistency of the results. Results. The number of randomized controlled trials identified varied widely with regard to the interventions involved. The scores ranged from 20 to 79 points for acute low back pain and from 19 to 79 points for chronic low back pain on a 100‐point scale, indicating the overall poor quality of the trials. Overall, only 28 (35%) randomized controlled trials on acute low back pain and 20 (25%) on chronic low back pain had a methodologic score of 50 or more points, and were considered to be of high quality. Various methodologic flaws were identified. Strong evidence was found for the effectiveness of muscle relaxants and nonsteroidal anti‐inflammatory drugs and the ineffectiveness of exercise therapy for acute low back pain; strong evidence also was found for the effectiveness of manipulation, back schools, and exercise therapy for chronic low back pain, especially for short‐term effects. Conclusions. The quality of the design, execution, and reporting of randomized controlled trials should be improved, to establish strong evidence for the effectiveness of the various therapeutic interventions for acute and chronic low back pain.
Pain rating scales, such as the Visual Analogue Scale (VAS) and the Verbal Rating Scale (VRS) are important tools for assessing patients’ symptom status. For a non-English speaking patient, VRS could pose a problem as a result of language barrier. The objective of this study was to determine the intra-class and inter-class correlations of VAS and a Semantic Differential Scale (SDS) in patients with low back pain. 25 patients with chronic low back pain were purposively selected for the study. Two testers (1 and 2) independently rated the pain experienced by the patients when asked to bend forward and hold on when pain was either exacerbated or aggravated. Finger-to-floor distance (FFD) was taken, as a measure of flexion of the spine, for each patient. Pain was rated using VAS and SDS. Our results showed strong intra-tester correlations between VAS and SDS of each tester (p < .05), and strong inter-tester correlations for VAS and for SDS (p < .05). The result of using two-way ANOVA showed that there was no significant difference in pain ratings with VAS by tester-1, VAS by tester-2, SDS by tester-1, and SDS by tester-2. F-ratio was not significant (p > .05). There was no significant difference between FFDs by the two testers (p > .05). Our results suggest that the two scales are reliable and valid for clinical rating of low back pain. Further studies with larger samples and using other movements of the spine are suggested.
In a randomized trial, the effectiveness of manual therapy, physiotherapy, continued treatment by the general practitioner, and placebo therapy (detuned ultrasound and detuned short-wave diathermy) were compared for patients (n = 256) with nonspecific back and neck complaints lasting for at least 6 weeks. The principle outcome measures were severity of the main complaint, global perceived effect, pain, and functional status. These are presented for 3, 6, and 12 weeks follow-up. Both physiotherapy and manual therapy decreased the severity of complaints more and had a higher global perceived effect compared to continued treatment by the general practitioner. Differences in effectiveness between physiotherapy and manual therapy could not be shown. A substantial part of the effect of manual therapy and physiotherapy appeared to be due to nonspecific (placebo) effects.
To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints.
Randomised clinical trial.
Primary health care in the Netherlands.
256 patients with non-specific back and neck complaints of at least six weeks' duration who had not received physiotherapy or manipulative therapy in the past two years.
At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes).
Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients.
Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months' follow up was similar for both treatments.
Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.
There are strong arguments for publishing research protocols before the results are available. First, it permits a critical judgment of the design unbiased by knowledge of the results, and second it may prevent publication bias. We present the design of a randomized trial on the effectiveness of manual therapy, physiotherapy, (continued) treatment by the general practitioner and a placebo treatment for patients (n = 300) with chronic (more than 6 wk) nonspecific back and neck complaints. In designing this trial in close cooperation with manual therapists and physiotherapists, special attention has been given to inclusion and exclusion criteria, (blinded) outcome measurements and control (placebo) treatment(s). Outcome measures include severity of complaints rated by a blinded research assistant, global perceived effect assessed by the patient, pain severity, functional status, range of motion (ROM) of the spine and recurrence. Measurements are carried out at baseline and after 3 wk, 6 wk, 3 months, 6 months and 1 yr.
To study the relationship between the methodological quality and other characteristics of reviews of spinal manipulation for low back pain on the one hand and the reviewers' conclusions on the effectiveness of manipulation on the other hand.
Reviews identified by MEDLINE search, citation tracking, library search, and correspondence with experts.
English- or Dutch-language reviews published up to 1993 dealing with spinal manipulation for low back pain that include at least two randomized clinical trials (RCTs).
Methodological quality was assessed using a standardized criteria list applied independently by two assessors (range, 0% to 100%). Other extracted characteristics were the comprehensiveness of the search, selective citation of studies, language, inclusion of non-RCTs, type of publication, reviewers' professional backgrounds, and publication in a spinal manipulation journal or book. The reviewers' conclusions were classified as negative, neutral, or positive.
A total of 51 reviews were assessed, 17 of which were neutral and 34 positive. The methodological quality was low, with a median score of 23%. Nine of the 10 methodologically best reviews were positive. Other factors associated with a positive reviewers' conclusion were review of spinal manipulation only, inclusion of a spinal manipulator in the review team, and a comprehensive literature search.
The majority of the reviews concluded that spinal manipulation is an effective treatment for low back pain. Although, in particular, the reviews with a relatively high methodological quality had a positive conclusion, strong conclusions were precluded by the overall low quality of the reviews. More empirical research on the review methods applied to other therapies in other professional fields is needed to further explore our findings about the factors related to a positive reviewers' conclusion.
A systematic review of randomized controlled trials.
To assess the effectiveness of the most common conservative types of treatment for patients with acute and chronic nonspecific low back pain.
Many treatment options for acute and chronic low back pain are available, but little is known about the optimal treatment strategy.
A rating system was used to assess the strength of the evidence, based on the methodologic quality of the randomized controlled trials, the relevance of the outcome measures, and the consistency of the results.
The number of randomized controlled trials identified varied widely with regard to the interventions involved. The scores ranged from 20 to 79 points for acute low back pain and from 19 to 79 points for chronic low back pain on a 100-point scale, indicating the overall poor quality of the trials. Overall, only 28 (35%) randomized controlled trials on acute low back pain and 20 (25%) on chronic low back pain had a methodologic score of 50 or more points, and were considered to be of high quality. Various methodologic flaws were identified. Strong evidence was found for the effectiveness of muscle relaxants and nonsteroidal anti-inflammatory drugs and the ineffectiveness of exercise therapy for acute low back pain; strong evidence also was found for the effectiveness of manipulation, back schools, and exercise therapy for chronic low back pain, especially for short-term effects.
The quality of the design, execution, and reporting of randomized controlled trials should be improved, to establish strong evidence for the effectiveness of the various therapeutic interventions for acute and chronic low back pain.
This article presents information about the development and evaluation of the SF-36 Health Survey, a 36-item generic measure of health status. It summarizes studies of reliability and validity and provides administrative and interpretation guidelines for the SF-36. A brief history of the International Quality of Life Assessment (IQOLA) Project is also included.
This paper reports the results of a 'cost-of-illness' study of the socio-economic costs of back pain in the UK. It estimates the direct health care cost of back pain in 1998 to be pound1632 million. Approximately 35% of this cost relates to services provided in the private sector and thus is most likely paid for directly by patients and their families. With respect to the distribution of cost across different providers, 37% relates to care provided by physiotherapists and allied specialists, 31% is incurred in the hospital sector, 14% relates to primary care, 7% to medication, 6% to community care and 5% to radiology and imaging used for investigation purposes. However, the direct cost of back pain is insignificant compared to the cost of informal care and the production losses related to it, which total pound10668 million. Overall, back pain is one of the most costly conditions for which an economic analysis has been carried out in the UK and this is in line with findings in other countries. Further research is needed to establish the cost-effectiveness of alternative back pain treatments, so as to minimise cost and maximise the health benefit from the resources used in this area.
Although spinal manipulation is one of the few interventions for low back pain supported by evidence, it appears to be underutilized by physical therapists, possibly due to therapists' concerns that a patient may not benefit from the intervention. The purpose of this study was to identify factors that are associated with an inability to benefit from manipulation.
Seventy-five people with nonradicular low back pain (mean age=37.6 years, SD=10.6, range=19-59; mean duration of symptoms=41.7 days, SD=54.7, range=1-252) participated.
Subjects underwent a standardized examination that included history-taking; self-reports of pain, disability, and fear-avoidance beliefs; measurement of lumbar and hip range of motion; and use of various tests. All subjects received a spinal manipulation intervention for a maximum of 2 sessions. Subjects who did not show greater than 5 points of improvement on the modified Oswestry Low Back Pain Disability Questionnaire were considered to have shown no improvement with the manipulation. Baseline variables were tested for univariate relationship with the outcome of the manipulation. Variables showing a univariate relationship were entered into a logistic regression equation, and adjusted odds ratios were calculated.
Twenty subjects (28%) did not improve with manipulation. Six variables were identified as being related to inability to improve with manipulation: longer symptom duration, having symptoms in the buttock or leg, absence of lumbar hypomobility, less hip rotation range of motion, less discrepancy in left-to-right hip medial rotation range of motion, and a negative Gaenslen sign. The resulting logistic regression model explained 63% of the variance in manipulation outcome.
The majority of subjects improved with manipulation. Baseline variables could be identified that were predictive of which subjects would not improve.
This descriptive review provides a summary of the prevalence, activity limitation (disability), care-seeking, natural history and clinical course, treatment outcome, and costs of low back pain (LBP) in primary care.
LBP is a common problem affecting both genders and most ages, for which about one in four adults seeks care in a six-month period. It results in considerable direct and indirect costs, and these costs are financial, workforce and social. Care-seeking behaviour varies depending on cultural factors, the intensity of the pain, the extent of activity limitation and the presence of co-morbidity. Care-seeking for LBP is a significant proportion of caseload for some primary-contact disciplines. Most recent-onset LBP episodes settle but only about one in three resolves completely over a 12-month period. About three in five will recur in an on-going relapsing pattern and about one in 10 do not resolve at all. The cases that do not resolve at all form a persistent LBP group that consume the bulk of LBP compensable care resources and for whom positive outcomes are possible but not frequent or substantial.
Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain (LBP) that are likely to benefit from a lumbo-pelvic thrust manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result similar outcomes. The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR.
Consecutive patients with LBP referred to physical therapy clinics in one of four geographical locations who satisfy the CPR will be invited to participate in this randomized clinical trial. Subjects who agree to participate will undergo a standard evaluation and complete a number of patient self-report questionnaires including the Oswestry Disability Index (OSW), which will serve as the primary outcome measure. Following the baseline examination patients will be randomly assigned to receive the lumbopelvic manipulation used in the development of the CPR, an alternative lumbar manipulation technique, or non-thrust lumbar mobilization technique for the first 2 visits. Beginning on visit 3, all 3 groups will receive an identical standard exercise program for 3 visits (visits 3,4,5). Outcomes of interest will be captured by a therapist blind to group assignment at 1 week (3rd visit), 4 weeks (6th visit) and at a 6-month follow-up. The primary aim of the study will be tested with analysis of variance (ANOVA) using the change in OSW score from baseline to 4-weeks (OSWBaseline - OSW4-weeks) as the dependent variable. The independent variable will be treatment with three levels (lumbo-pelvic manipulation, alternative lumbar manipulation, lumbar mobilization).
This trial will be the first to investigate the effectiveness of various manual therapy techniques for patients with LBP who satisfy a CPR.
Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard) methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment.
We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs) assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment), or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography), or adjudications of clinical events.
This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.
A prospective, cohort study of patients with nonradicular low back pain referred to physical therapy.
Develop a clinical prediction rule for identifying patients with low back pain who improve with spinal manipulation.
Development of clinical prediction rules for classifying patients with low back pain who are likely to respond to a particular intervention, such as manipulation, would improve clinical decision-making and research.
Patients with nonradicular low back pain underwent a standardized examination and then underwent a standardized spinal manipulation treatment program. Success with treatment was determined using percent change in disability scores over three sessions and served as the reference standard for determining the accuracy of examination variables. Examination variables were first analyzed for univariate accuracy in predicting success and then combined into a multivariate clinical prediction rule.
Seventy-one patients participated. Thirty-two had success with the manipulation intervention. A clinical prediction rule with five variables (symptom duration, fear-avoidance beliefs, lumbar hypomobility, hip internal rotation range of motion, and no symptoms distal to the knee) was identified. The presence of four of five of these variables (positive likelihood ratio = 24.38) increased the probability of success with manipulation from 45% to 95%.
It appears that patients with low back pain likely to respond to manipulation can be accurately identified before treatment.
Objective: To estimate the effect of adding exercise classes, spinal manipulation delivered in NHS or private premises, or manipulation followed by exercise to "best care" in general practice for patients consulting with back pain. Design: Pragmatic randomised trial with factorial design. Setting: 181 general practices in Medical Research Council General Practice Research Framework; 63 community settings around 14 centres across the United Kingdom. Participants: 1334 patients consulting their general practices about low back pain. Main outcome measures: Scores on the Roland Morris disability questionnaire at three and 12 months, adjusted for centre and baseline scores. Results: All groups improved over time. Exercise improved mean disability questionnaire scores at three months by 1.4 (95% confidence interval 0.6 to 2.1) more than "best care." For manipulation the additional improvement was 1.6 (0.8 to 2.3) at three months and 1.0 (0.2 to 1.8) at 12 months. For manipulation followed by exercise the additional improvement was 1.9 (1.2 to 2.6) at three months and 1.3 (0.5 to 2.1) at 12 months. No significant differences in outcome occurred between manipulation in NHS premises and in private premises. No serious adverse events occurred. Conclusions: Relative to "best care" in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.
Objective.
—To study the relationship between the methodological quality and other characteristics of reviews of spinal manipulation for low back pain on the one hand and the reviewers' conclusions on the effectiveness of manipulation on the other hand.
Data Sources.
—Reviews identified by MEDLINE search, citation tracking, library search, and correspondence with experts.
Study Selection.
—English- or Dutch-language reviews published up to 1993 dealing with spinal manipulation for low back pain that include at least two randomized clinical trials (RCTs).
Data Extraction.
—Methodological quality was assessed using a standardized criteria list applied independently by two assessors (range, 0% to 100%). Other extracted characteristics were the comprehensiveness of the search, selective citation of studies, language, inclusion of non-RCTs, type of publication, reviewers' professional backgrounds, and publication in a spinal manipulation journal or book. The reviewers' conclusions were classified as negative, neutral, or positive.
Data Synthesis.
—A total of 51 reviews were assessed, 17 of which were neutral and 34 positive. The methodological quality was low, with a median score of 23%. Nine of the 10 methodologically best reviews were positive. Other factors associated with a positive reviewers' conclusion were review of spinal manipulation only, inclusion of a spinal manipulator in the review team, and a comprehensive literature search.
Conclusions.
—The majority of the reviews concluded that spinal manipulation is an effective treatment for low back pain. Although, in particular, the reviews with a relatively high methodological quality had a positive conclusion, strong conclusions were precluded by the overall low quality of the reviews. More empirical research on the review methods applied to other therapies in other professional fields is needed to further explore our findings about the factors related to a positive reviewers' conclusion.(JAMA. 1995;274:1942-1948)
Back pain is an important problem for primary care physicians; it is common, costly, and controversial. Back pain is the second leading symptom prompting all physician visits in the United States. There are wide geographic variations in medical care for this problem, and surgical rates in the United States are twice those of most developed countries. The treatment of back pain has followed a series of fads and fashions, and work disability resulting from back pain continues to rise. For all these reasons, primary care clinicians have an important role in improving the care of patients with low back pain. Primary care clinicians face unique problems in treating these patients. First, in primary care, most patients have uncomplicated low back pain, and identifying the rare patient with an underlying malignancy or neurologic deficit is like looking for a needle in a haystack. Second, these practitioners face two populations with nonspecific back pain: one that is likely to improve no matter what (who mostly need reassurance), and a smaller group (about 20%) who are prone to development of chronic back pain and who present complex psychosocial and occupational problems. Third, these problems must be dealt with in the typical setting of a 15‐minute patient visit. Finally, lifestyle changes in exercise, weight loss, and smoking cessation may be major parts of patient treatment, and improving compliance with such interventions always is a major challenge. Primary care investigators studying back pain face at least three important challenges. One is to identify more efficient diagnostic strategies that will alleviate doctors' and patients' anxieties. Second is to develop a better theory to explain the large majority of episodes of nonspecific low back pain. At present, competing theories generate competing and conflicting treatments, generating frustration among patients and loss of credibility for clinicians. Third, we need better science, with greater methodologic rigor in the evaluation of the many nonsurgical treatments used for back pain in the primary care setting.
Study design:
A randomized trial was conducted on a representative sample of patients with untreated low back pain lasting 7 weeks or longer, or having more than 6 episodes in 12 months.
Objectives:
To contrast the effectiveness of manipulation, a manipulation mimic, and a back education program. Methodologic criticisms of earlier studies were addressed.
Summary of background data:
Published meta-analyses suggest clinical benefit from manipulation for acute patients. Data are inconclusive for patients having symptoms for longer than 1 month.
Methods:
A total of 1267 consecutive patients were screened. Block randomization was used to assign 209 qualifying patients to treatment groups. Self-reported pain and activity tolerance served as primary outcome measures. Patients were assessed at enrollment, after 2 weeks of treatment, and again after 2 weeks without treatment. Multiple teams conducted recruitment, randomization, assessment, treatment, and data analysis independently without sharing information. Treatments were carefully described, monitored, and balanced for physician attention and physical contact effects.
Results:
A total of 81.3% of subjects completed the study. Confounding factors and missing data were identified in approximately 20% of those completing the final follow-up. Analysis of the remaining data was carried out. A strong time effect under treatment was observed. Greater improvement was noted in pain and activity tolerance in the manipulation group. Immediate benefit from pain relief continued to accrue after manipulation, even for the last encounter at the end of the 2-week treatment interval.
Conclusion:
Time is a strong ally of the low back pain patient. In human terms, however, there appears to be clinical value to treatment according to a defined plan using manipulation even in low back pain exceeding 7 weeks' duration.
Objective: To estimate the effect of adding exercise classes, spinal manipulation delivered in NHS or private premises, or manipulation followed by exercise to "best care" in general practice for patients consulting with back pain.
Design: Pragmatic randomised trial with factorial design.
Setting: 181 general practices in Medical Research Council General Practice Research Framework; 63 community settings around 14 centres across the United Kingdom.
Participants: 1334 patients consulting their general practices about low back pain.
Main outcome measures: Scores on the Roland Morris disability questionnaire at three and 12 months, adjusted for centre and baseline scores.
Results: All groups improved over time. Exercise improved mean disability questionnaire scores at three months by 1.4 (95% confidence interval 0.6 to 2.1) more than "best care." For manipulation the additional improvement was 1.6 (0.8 to 2.3) at three months and 1.0 (0.2 to 1.8) at 12 months. For manipulation followed by exercise the additional improvement was 1.9 (1.2 to 2.6) at three months and 1.3 (0.5 to 2.1) at 12 months. No significant differences in outcome occurred between manipulation in NHS premises and in private premises. No serious adverse events occurred.
Conclusions: Relative to "best care" in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.
To review the use, complications, and efficacy of spinal manipulation as a treatment for low-back pain.
Articles were identified through a MEDLINE search, review of articles' bibliographies, and advice from expert orthopedists and chiropractors.
All studies reporting use and complications of spinal manipulation and all controlled trials of the efficacy of spinal manipulation were analyzed. Fifty-eight articles, including 25 controlled trials, were retrieved.
Data on the use and complications of spinal manipulation were summarized. Controlled trials of efficacy were critically appraised for study quality. Data from nine studies were combined using the confidence profile method of meta-analysis to estimate the effect of spinal manipulation on patients' pain and functional outcomes.
Chiropractors provide most of the manipulative therapy used in the United States for patients with low-back pain. Serious complications of lumbar manipulation, including paraplegia and death, have been reported. Although the occurrence rate of these complications is unknown, it is probably low. For patients with uncomplicated, acute low-back pain, the difference in probability of recovery at 3 weeks favoring treatment with spinal manipulation is 0.17 (for example, increase in recovery from 50% to 67%; 95% probability limits of estimate, 0.07 to 0.28). For patients with low-back pain and sciatic nerve irritation, the difference in probabilities of recovery at 4 weeks is 0.098 (probability limits, -0.016 to 0.209).
Spinal manipulation is of short-term benefit in some patients, particularly those with uncomplicated, acute low-back pain. Data are insufficient concerning the efficacy of spinal manipulation for chronic low-back pain.
The use of manual therapy to treat somatic pain syndromes and associated disabilities is widespread. Yet, the efficacy of manual therapy has not been previously established because equivocal findings in the literature prevent definitive conclusions. The purposes of this article are (1) to establish objective criteria for judging the validity of manual therapy research, (2) to identify and discuss the results of those trials that were determined to be valid demonstrations of treatment efficacy or valid demonstrations of nonuseful therapy, and (3) to determine whether patients who benefit from manual therapy have common characteristics. The abstracts or full reports of 146 titles with appropriate key words were reviewed. Of these, 105 studies were not primary studies of manual therapy and were thus eliminated from review. In the 41 remaining studies, 18 did not utilize statistical comparisons or report blinded assessment of outcome measures. Nine controlled studies yielded negative results, but the statistical power or minimum sample size required to detect potential differences between manual therapy and control groups was not described. The 14 studies that met the efficacy criteria were categorized by the following factors: (1) the anatomical region of intervention, (2) pragmatic versus explanatory goals, and (3) primary intervention (manipulation, mobilization, combination). There was a paucity of valid explanatory research in all areas and a particular absence of controlled trials involving manual therapy applied to the peripheral joints. Manual therapy for low back pain, however, was studied extensively. The analysis of valid trials provided clear evidence that manual therapy, particularly manipulation, can be an effective modality when used to treat patients who have low back pain. A preliminary "profile" of the patient with low back pain who would likely benefit from manual therapy included acute symptom onset with less than a 1-month duration of symptoms, central or paravertebral pain distribution, no previous exposure to spinal manipulation, and no pending litigation or workers' compensation. Suggestions for future manual therapy research are discussed.
To assess the efficacy of spinal manipulative therapy (SMT) in the treatment of back pain using meta-analytical techniques.
The literature was systematically searched for all studies of SMT through June 1989. The Index Medicus from 1980 was expanded by citation tracking. The Chiropractic Research Archives Collection was utilized as a regularly updated bibliographic source for the location of research publications. A hand search of professional chiropractic journals was also undertaken.
Studies in English with concurrent controls treated by methods other than SMT, including sham, produced 23 randomized controlled clinical trials of the effectiveness of spinal manipulation. Because a single trial might include more than one comparison of treatments, these trials produced a total of 34 mutually exclusive, discrete samples.
Data were extracted via a standardized coding document by one author and verified by two of the others. Data were independently extracted from a subset of the studies by a blinded research assistant to ensure that coding methods produced acceptable consistency.
Effect sizes (Cohen's D index) were calculated for nine outcome variables at eight time points following the initiation of treatment. Thirty-eight of 44 effect sizes indicated that SMT was better than the comparison treatment. It was also found that meta-analysis was an imperfect instrument for the kind of trials that were pooled in this study because the research protocols were highly diverse. Furthermore, because the nature of SMT does not permit an easy use of placebos, true no-treatment control groups were rare. Most studies compared SMT to an alternative treatment. This probably obscured the effectiveness of SMT since the comparison treatments were presumably also effective.
SMT proved to be consistently more effective in the treatment of low back pain than were any of the array of comparison treatments. The analysis provided some suggestion that manipulation, as such, is more effective than mobilization, as such. For the future, it is suggested that researchers strive for more consistent measures in terms of explicit descriptions of the nature of SMT, the times of post-treatment assessments and the nature of outcome measures. Only then can meta-analysis fulfill its potential in this clinical area.