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Low Back Pain of Mechanical Origin: Randomized Comparison of Chiropractic and Hospital Outpatient Treatment 1
Abstract and Figures
Reprinted with permission from the British Medical Journal 300:1431-1437.1990. Objective - To compare chiropractic and hospital outpatient treatment for managing low back pain of mechanical origin.Design - Randomized controlled trial. Allocation to chiropractic or hospital management by minimization to establish groups for analysis of results according to initial referral clinic, length of current episode, history, and severity of back pain. Patients were followed up for up to two years.Setting - Chiropractic and hospital outpatient clinics in 11 centers.Patients - 741 patients aged 18-65 who had no contraindications to manipulation and who had not been treated within the past month.Interventions - Treatment at the discretion of the chiropractors, who used chiropractic manipulation in most patients, or of the hospital staff, who most commonly used Maitland mobilization or manipulation, or both.Main outcome measures - Changes in the score on the Oswestry pain disability questionnaire and in the results of tests of straight leg raising and lumbar flexion.Results - Chiropractic treatment was more effective than hospital outpatient management, mainly for patients with chronic or severe back pain. A benefit of about 7 percent points on the Oswestry scale was seen at two years. The benefit of chiropractic treatment became more evident throughout the follow-up period. Secondary outcome measures also showed that chiropractic was more beneficial.Conclusions - For patients with low back pain in whom manipulation is not contraindicated, chiropractic almost certainly confers worthwhile, long-term benefit in comparison with hospital outpatient management. The benefit is seen mainly in those with chronic or severe pain. Introducing chiropractic into NHS practice should be considered.J Orthop Sports Phys Ther 1991;13(6):278-287.
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... Many studies support spinal manipulation for acute LBP, resulting in both short-term benefits 7-10 and long-term benefits of 1 to 3 years. [11][12][13][14] Many systematic reviews discussed trials on efficacy of spinal manipulation; and other systematic reviews focused on harms related to spinal manipulation. [15][16][17][18] For acute low back pain, a higherquality Cochrane review found spinal manipulation to be slightly to moderately superior to sham manipulation for short-term pain relief during a meta-regression analysis. ...
Introduction: Spinal Root Compression Syndromes (SRCS) are common, costly, and significant cause of long-term sick leave and work loss. There is No consensus on the best approach. One intervention often used is manipulative therapy. Objective: The aim of this study was to determine if Single Vertebral Manipulative Therapy (Kitchener’s Technique) (SVMT) is effective in alleviating pain levels and regaining physical functioning in comparison to standard medical care (SMC), among 18-55-year-old active working personnel. Methods: Prospective, longitudinal, 2-arm controlled study comparing SMC plus SVMT (32 patients) with only SMC (21 patients). The primary outcome measures were changes in root-related pain on the numerical rating scale and physical functioning at 6 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). Results: Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus SVMT group than in the SMC group at both week 2 (P<0.001) and week 6 (P=0.001). Mean numerical rating scale pain scores were also significantly better in the group that received SVMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus SVMT group than in the SMC group at both week 2 (P<0.001) and week 6 (P=0.001). Conclusion: Results suggest that SVMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only SMC, for patients aged 18-55 years with SRCS.
... 17 Neurophysiological effects of SMT could theoretically influence sports performance. These include changes in surface electromyographic activity, 18,19 corticospinal [20][21][22] and spinal cord [22][23][24] excitability, increased muscle strength, 7,25,26 decreased muscle inhibition, 27,28 lower expression of proinflammatory cytokines, 29 decreased pain sensation, [30][31][32][33][34][35][36][37][38] and prevention of muscle fatigue. 39 It has been proposed that SMT may influence and improve aspects of sports performance. ...
Objective
The purpose of this study was to assess the feasibility of the procedures’ routine, the recruiting rate, the presence of any significant detrimental impact on the players’ training routine, and the sham efficacy in achieving blinding.
Methods
A parallel randomized controlled clinical trial was performed with 20 elite soccer players who were randomly assigned to 1 of 2 groups: spinal manipulative therapy (SMT) and sham SMT. All players were from the same team, were injury free, and were naive to SMT. Measured outcome tests (30-m sprint run with a 10-m split and change of direction [COD] test) were performed at the same time by all participants immediately before and after interventions. Photocell devices were used for data acquisition.
Results
Twenty participants were analyzed (10 in each group). There were no changes to the sprint (10 m and 30 m) and COD test results immediately after either of the interventions. All participants in both groups (SMT and sham SMT) answered “yes” to a question after the intervention asking if they were treated by SMT. No adverse effects or training routine impairment were reported.
Conclusion
This pilot study protocol showed it was an appropriate design for a confirmatory clinical trial. The study had minimal effect on the team training routine, and the recruitment rate was excellent. The proposed sham SMT strategy was successful in blinding the players. In this sample, SMT did not have any immediate effect on the performance of these elite soccer players, as measured by 10- and 30-m sprint times and COD sprint times.
... Many studies support spinal manipulation for acute LBP, resulting in both short-term benefits 7-10 and long-term benefits of 1 to 3 years. [11][12][13][14] Many systematic reviews discussed trials on efficacy of spinal manipulation; and other systematic reviews focused on harms related to spinal manipulation. [15][16][17][18] For acute low back pain, a higherquality Cochrane review found spinal manipulation to be slightly to moderately superior to sham manipulation for short-term pain relief during a meta-regression analysis. ...
Introduction: We conducted an open label clinical to assess if beta 2 microglobulin (B2M) can be useful as prognostic factor that can increase the usefulness of International Prognostic Index (IPI)in patients with aggressive lymphoma ; with stage IV and high clinical risk. Methods: Between January 1999 to December 2015, 1388 patients with aggressive lymphoma ,in that were classified as high-clinical risk and stage IV, treated with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or R-CHOP (CHOP+rituximab); B2M was adding to the staging procedures; they were classified in two groups: normal (< 3.0 mg/L) or elevated ( >3.0 mg/L) levels that were compared in response type and outcome. Results: Complete response, actuarial curves of progression-free survival and overall survival, were statistically better in patients with normal levels of B2M: 68%; 78% (95% Confidence interval(CI):(69% - 83%)) and 73%(95%CI: 67%-82 %) ; and 73% (95%CI:67%-81%) compared with patients with high levels were: 54%; 58%(95%CI; 48%-67%); and 47% (95%CI:39%-58%), (p <0.001) respectively. Multivariable analysis confirm that B2M and lactate dehydrogenase have powerful to detect a worse prognostic course. Conclusion: B2M appear to be a no-expensive, simple and reproducible marker to help defined an worse prognosis in patients with high clinical risk and advanced stage. Thus, will be considered to planned a clinical trial to test the efficacy of different chemotherapeutic regimens in these setting of patients.
... Several of the neurophysiological effects of SMT that have been demonstrated in studies could theoretically in uence sports performance. These include changes in surface electromyographic activity [18,19], corticospinal [20][21][22] and spinal cord [22][23][24] excitability, muscle strength [7,25,26], muscle inhibition [27,28], expression of proin ammatory cytokines [29], pain sensation [30][31][32][33][34][35][36][37][38], and prevention of muscle fatigue [39]. ...
Background
Asymptomatic spinal biomechanical alterations may generate impaired central nervous system proprioceptive input, and motor control, and central processing deficits, which could impair sports performance. Several of the demonstrated neurophysiological effects of spinal manipulative therapy (SMT) could theoretically influence sports performance. Further, some studies have demonstrated that SMT' may improve aspects of sports performance. These include improved full-swing in golfers, judoka grip strength, taekwondo muscle strength, and ball kicking speed in soccer. The purpose of this study was to assess the effect on the performance of elite athletes of one session of SMT to correct asymptomatic, biomechanical dysfunction, using professional soccer players and sprint and change of direction (COD) tests. Also, the proposed placebo intervention was tested for efficacy in achieving blinding.
Methods
A parallel-randomized, controlled, clinical trial was performed with 20 elite soccer players who were randomly assigned to one of two groups by a coin flip: one receiving SMT (n=10) and the other a placebo intervention (n=10). All players were from the same team, and were injury free and naive to SMT. Data were collected at the team training facility. Measured outcome tests (30-meter sprint run with a 10-meter split and COD test) were performed at the same time by all subjects immediately prior to and after interventions. Photocell devices were used for data acquisition. Participants and those assessing outcomes were blinded to group assignment. Care givers were not able to be blinded.
Results
20 participants were analyzed, 10 in each group. There were no changes to the sprint (10m and 30m) and COD test results immediately following either of the interventions. All subjects (SMT and placebo) answered YES to a question after the intervention asking if they were treated by SMT. No adverse events were reported.
Conclusion
Spinal manipulative therapy to correct asymptomatic, biomechanical dysfunction in the spine and pelvis did not have any immediate effect on the performance of elite soccer players as measured by 10- and 30-meters sprint times and COD sprint times. Additionally, the proposed placebo strategy was successful in blinding these athletes.
Trial registration
ISRCTN29691307. Retrospectively registered in 07/02/2018.
http://www.isrctn.com/ISRCTN29691307.
... It has been reported that the frequency of medical visits is greater when patients are receiving OMT as opposed to standard allopathic care. 21,22 An increase in medical visits could introduce its own placebo effect, but this is not relevant to this study as the number of visits were identical. Documenting medical costs, however, may provide additional evidence of the benefits associated with OMT. ...
Context
Osteopathic manipulative treatment (OMT) is a widely used methodology for the clinical treatment of spine-related pain. Recent reports have been especially positive regarding the use of OMT for chronic back pain. However, published reports have been focused on populations available within large university-based institutions, with rural-based hospitals and their clientele unrepresented within the professional literature
Objective
The objective of this multi-year study was to examine the effects of OMT on spine-related chronic pain and its effects on dimensions of functional ability in a rural setting served by a safety-net hospital.
Methods
In this study, 151 participants with chronic (>6 months) spine-related pain (mean age 54.58 ± 11.88 years) completed at least 2 office visits. The Oswestry Disability Index (ODI) was used to assess 10 dimensions (pain intensity, personal care, lifting, walking, sitting, sleeping, standing, sex life, social life, and travel) and a total score of functional ability related to back pain.
Results
A 2-way mixed-model, repeated-measures analysis of variance (ANOVA) with time (pre- and post-office visit) as the within-participants factor and with sex as the between-participants factor resulted in a significant main effect from pretest to posttest, (F(1,149) = 67.12, P < .001, η2p = .311), but not a significant interaction between time and gender, (F(1,149) = .426, P = .515, η2p = .003).
Conclusions
The results of this study support the hypothesis that OMT improved measures of functional ability related to pain intensity, unrelated to sex. The rural nature of the clinical setting provided a unique population for this study.
... Les manipulations permettent d'obtenir un soulagement symptomatique rapide des lombalgies aiguës non spécifiques [16][17][18] et des phénomènes secondaires (par ex. contractures musculaires), mais sans être, à vrai dire, franchement supérieures aux autres formes de traitement [19]. ...
... 44 Meade et al examined chiropractic care's effectiveness for CLBP, compared to hospital outpatient treatment. 45 Chiropractic treatment was more effective than hospital outpatient treatment for improving pain disability and flexibility tests of leg straightening and lumbar flexion in patients with CLBP. ...
Pain and pain management are a growing concern among Americans age 65 and older. A recent analysis of data from a National Institutes of Health (NIH)-funded study found that more than half (53%) of the older adults surveyed reported having bothersome pain in the last month; three-quarters of them reported having pain in more than 1 location. Bothersome pain, particularly in multiple locations, also was associated with decreased physical capacity... In this article, the authors present a variety of treatment options, ranging from medications, comorbid mental health issues, and comprehensive interdisciplinary pain management.
Full article found here: https://www.practicalpainmanagement.com/treatments/pain-management-elderly
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.
In controlled clinical trials, the treatments are likely to be influenced by various prognostic factors, and while assigning treatments sequentially to the patients it is desirable to allot the treatments in such a way that the treatments are balanced over the main effects of prognostic factors and also on some or all interactions between the prognostic factors if the interactions are present. Efran (1971), Pocock and Simon (1975) and Freedman and White (1976) described some methods of balancing the treatments over the prognostic factors. In this paper, we shall describe a new approach in assigning the treatments using multivariate methods.
The author describes the problems of conducting and interpreting clinical trials in this difficult area, with special reference to those trials which have already been published, in the hope of guiding the clinician towards a more rational approach to therapy. As certain aspects of treatment, namely chemonucleolysis and surgery, are the subjects of the other chapters, they will be excluded from the discussion.
This is the report of a feasibility study of a randomised controlled trial of chiropractic and hospital outpatient management for low back pain of mechanical origin. Preparations for the study included an approach to the General Medical Council for guidance about the intended collaboration between medically qualified and heterodox practitioners, detailed communication with local general practitioners, and the provision of a Medical Research Council (MRC) grant to cover payments to the chiropractors for work carried out in the course of the study. A total of 238 patients were considered, 197 of whom had initially presented to Northwick Park Hospital and the remaining 41 to the chiropractic clinic in Harrow. Only 6% of the patients presenting to the hospital refused to enter. The single most frequent reason for ineligibility in the hospital patients was freedom from pain at the time of the first hospital visit (23%). A variety of medical contraindications accounted for the exclusion of a further 24% of hospital patients. Patients presenting to the chiropractice group tended to have had shorter current episodes of back pain but to have had more NHS treatment in the past than those presenting to hospital. The commonest reason for exclusion among those presenting to the chiropractic clinic was refusal to enter (34%). Only 5% of the chiropractic patients were ineligible for medical reasons. Overall, 16% of those presenting to hospital and 44% of those presenting to the chiropractors were eligible and willing to enter the randomised treatment phase of the study. Of the 50 patients who entered the treatment phase, all but seven completed treatment and the six weekly self-completed assessments of progress. Patients whose current episodes had lasted less than a month progressed significantly more rapidly than those with longer current episodes. It is likely that sufficient numbers of patients with low back pain are prepared to take part in a formal randomised controlled trial. The organisation and working methods for such a trial appear to be feasible. A full scale multicentre trial should aim to include about 2000 patients.
In controlled clinical trials there are usually several prognostic factors known or thought to influence the patient's ability to respond to treatment. Therefore, the method of sequential treatment assignment needs to be designed so that treatment balance is simultaneously achieved across all such patients factor. Traditional methods of restricted randomization such as "permuted blocks within strata" prove inadequate once the number of strata, or combinations of factor levels, approaches the sample size. A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor. The improved treatment balance obtained by this approach is explored using simulation for a simple model of a clinical trial. Further discussion centers on the selection, predictability and practicability of such a procedure.
The questionnaire is divided into ten sections selected from a series of experimental questionnaires designed to assess limitations of various activities of daily living. The chosen sections were those found to be most relevant to the problems suffered by people with low back pain. Each section contains six statements. A study of 25 patients with primary low back pain has already been mentioned. Their symptoms tended to resolve quickly and changes in their mean disability score can be seen over the first three weeks after referral to the spinal disorders department. The disability score was also used to demonstrate that there was no difference in the severity of symptoms in two sub-groups of patients in the same study. All new patients referred to the department complete the questionnaire when they first attend. The disability score is used as a guide to a patient's treatment programme. It cannot be used in isolation since it makes no allowance for the demands of a patient's job, his age or psychological make-up. However, it does ensure that important aspects of disability which are often forgotten are recorded in the patient's notes. Later, changes in the score may be used in monitoring the subsequent progress of the patient through treatment.