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Outcomes After a Prone Lumbar Traction Protocol for Patients With Activity-Limiting Low Back Pain: A Prospective Case Series Study
Abstract
To determine outcomes after administration of a prone lumbar traction protocol.
Prospective, longitudinal, case series.
Suburban, chiropractic practice.
A total of 296 subjects with low back pain (LBP) and evidence of a degenerative and/or herniated intervertebral disk at 1 or more levels of the lumbar spine. We excluded patients involved in litigation and those receiving workers' compensation.
An 8-week course of prone lumbar traction, using the vertebral axial decompression (VAX-D) system, consisting of five 30-minute sessions a week for 4 weeks, followed by one 30-minute session a week for 4 additional weeks.
The numeric pain rating scale and the Roland-Morris Disability Questionnaire (RMDQ) were completed at preintervention, discharge (within 2 weeks of the last visit), and at 30 days and 180 days after discharge. Intention-to-treat strategies were used to account for those subjects lost to follow-up.
A total of 250 (84.4%) subjects completed the treatment protocol. On the 30-day follow-up, 247 (83.4%) subjects were available; on the 180-day follow-up, data were available for 241 (81.4%) subjects. We noted significant improvements for all postintervention outcome scores when compared with preintervention scores (P<.01).
Traction applied in the prone position using the VAX-D for 8 weeks was associated with improvements in pain intensity and RMDQ scores at discharge, and at 30 and 180 days after discharge in a sample of patients with activity-limiting LBP. Causal relationships between these outcomes and the intervention should not be made until further study is performed using randomized comparison groups.
... A distinct retrospective study also showed benefit with motorized spinal decompression over standard pelvic traction [22]. Beattie et al. conducted an 8-week course of VAX-D and observed significant outcome improvements for all the post-intervention scores when compared with the pre-intervention score [23]. Despite these projected neurologic or/and mechanical mechanisms of action, currently, there is no clear consensus regarding the amount of force to apply in LT interventions. ...
... Beattie et al 2007 [23] Diagnostic imaging evidence of a degenerative and/or herniated intervertebral disk. ...
... All the trials contained in our study were randomizedcontrolled parallel studies. The method of randomization was reported in five trials [21,23,32,33]. Beattie et al [23] study determined short-and long-term outcomes by using the VAX-D protocol after administration of prone traction. ...
... 2,4,[9][10][11] Mechanical lumbar traction, which is one of the previously mentioned modalities, has been used to treat spinal disorders and LBP for centuries, since Hippocrates (5th-4th century BC). 12,13 Evidence-based guidelines and systematic reviews have generally not supported the use of traction for patients with LBP because of the lack of high-quality studies, heterogeneous patient samples, and lack of power. [14][15][16] Despite the lack of evidence, traction is widely used, ranging from 41% to 76% of therapists, 5,17 often in combination with other treatments without any clear consensus in terms of treatment parameters such as type, duration, frequency, force, or patient position. ...
... 14,[16][17][18][19] Although the supine position is generally preferred by therapists, 18,20 the patient may also be positioned prone during traction treatment. 13,21,22 To achieve the optimal beneficial effects of traction, patient comfort and muscle relaxation are considered essential. 19,23 In a study by Weatherell,20 it was shown that sacrospinal muscles were relaxed in both supine and prone position during traction in normal subjects, and muscle activity was significantly less in the prone position compared with the supine position. ...
... The supine position is traditionally preferred during lumbar traction 14,18 ; nonetheless, traction can also be effectively applied in the prone position. 13,21,22 Patient comfort and muscle relaxation during traction are considered essential to achieve the optimal effects of the intervention. 19,22 Cyriax 23 postulated that lumber muscle relaxation was necessary to allow vertebral separation, which causes relief of "pinched" spinal nerves and reduction of protrusion. ...
Background
Mechanical lumbar traction has been used to treat spinal disorders and low back pain for centuries, since Hippocrates(.2,3Although the supine position is generally preferred, the patient may also be positioned prone during traction treatment(.4,5 However, to the best of our knowledge, no studies have compared the effects of lumbar traction in these two different positions for patients with chronic LBP.
Objectives
To compare the effects of mechanical lumbar traction either in the supine or prone position with conventional physical therapy(PT) in patients with chronic low back pain(LBP) and lumbosacral nerve root involvement in terms of disability, pain, and mobility.
Methods
Participants(n=125) were randomly assingned to receive 15 sessions of PT with additional mechanical lumbar traction either in the supine position (supine traction group), or in the prone position (prone traction group), or only PT without traction(PT only group). Patients were assessed at baseline and at the end of the PT sessions in terms of disability, pain, and mobility. Disability was assessed using the modified Oswesty Disability Index (ODI); pain was assessed using a visual analogue scale (VAS); and lumbar mobility was assessed using the modified lumbar Schober test (mLST).
Results
118 patients completed the trial. All groups improved significantly in the ODI, VAS, and mLST (p<0.05) (table 1). In the between-group analysis, improvements of ODI and VAS were found significantly better in the prone traction group compared with the PT only group (adjusted p=0.031 and.006, respectively).
Conclusions
Addition of traction in prone position to other modalities resulted in larger immediate improvements in terms of pain and disability, and the results suggest that when using traction, prone traction might be first-choice. Further research is needed to confirm the benefits of lumbar traction in the prone position.
References
[1] Marketos SG, Skiadas P. Hippocrates. The father of spine surgery. Spine1999;24:1381–7. [2] Krause M, Refshauge KM, Dessen M, et al. Lumbar spine traction: evaluation of effects and recommended application for treatment. Manual therapy2000;5:72–81.
[3] Harte AA, Gracey JH, Baxter GD. Current use of lumbar traction in the management of low back pain: results of a survey of physiotherapists in the UK. Archives of physical medicine and rehabilitation2005;86:1164–9.
[4] Fritz JM, Lindsay W, Matheson JW, et al. Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis. Spine2007;32:E793–800.
Disclosure of Interest
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Abstract THU0539 – Table 1
... A total of 14 studies published from 2006 to 2013 that reported clinical or radiological outcomes of lumbar traction treatment in LBP were finally included in the review. Among these 14 studies, 11 were randomized clinical trials [11,[24][25][26][27][28][29][30][31][32][33], 1 was a retrospective cohort study [34] and 2 were case series [35,36]. The total number of patients included in our review is 1104. ...
... The total number of patients included in our review is 1104. 12 studies were related specifically to nerve root compression symptoms [24][25][26][27][28]30,31,[33][34][35][36], 6 took into account degenerative disc disease, mechanic pain, hypolordosis or generic "chronic low back pain" alone or in association with nerve root compression symptoms [11,25,29,32,33,35]. In 12 studies, motorized traction was used [11,24,[26][27][28][29][30][32][33][34][35][36] when in 1 RTC manual traction was the declared physical therapy [25]. ...
... The total number of patients included in our review is 1104. 12 studies were related specifically to nerve root compression symptoms [24][25][26][27][28]30,31,[33][34][35][36], 6 took into account degenerative disc disease, mechanic pain, hypolordosis or generic "chronic low back pain" alone or in association with nerve root compression symptoms [11,25,29,32,33,35]. In 12 studies, motorized traction was used [11,24,[26][27][28][29][30][32][33][34][35][36] when in 1 RTC manual traction was the declared physical therapy [25]. ...
Introduction : Low back pain (LBP) is one of the most common complaints in the general population, affecting about 70-80% of the population at some point in life. LBP management comprises a wide range of different intervention strategies. One of the treatment options is traction therapy. The aim of our short review is to summarize and analyze the latest result reporting the use of lumbar traction in LBP treatment in order to evaluate the real effectiveness and indications of this specific physical therapy.
Materials and methods: A comprehensive search of PubMed, Medline, Cochrane, Embase, and Google Scholar databases was performed, covering the period between 2006 and 2013. 54 citations were obtained. Relevant data from each included study were extracted and recorded.
Results: A total of 14 studies were included in the review. Among these 14 studies, 11 were randomized clinical trials, 1 was a retrospective cohort study and 2 were case series. The majority of included studies used traction on patients that suffered nerve root compression symptoms. The mean number of traction sessions was 19. At most, the duration of each session was 30 min (range 3-30 min). The mean period of traction treatment was 6 weeks (range 3-12 weeks). 11 studies coupled with traction other therapies. Only 3 studies used traction as a single treatment. The mean follow up period was 16,5 weeks from the end of treatment.
Conclusion: Several biases can be introduced by limited quality evidence from the included studies. Lumbar traction seems to produce positive results in nerve root compression symptoms. Data in degenerative and discogenic pain are debatable. To date, the use of lumbar traction therapy alone in LBP management is not recommended by the best available evidence.
... Studies 30,31) have claimed that the new technologies used by these spinal decompression systems can decrease patients' protective proprioceptive responses to distraction allowing distraction of the spinal segment, thereby reducing intradiscal pressure and symptoms secondary to disc herniation. Other reports [32][33][34] have demonstrated improvements in visual analogue scale and/or in disability scales in patients with discogenic low back pain (LBP) after treatment with spinal decompression systems such as VAX-D and DRX9000. Although previous studies have reported that symptoms of acute and/or chronic LBP secondary to disc herniation might be relieved by intermittent axial decompression delivered via DRX9000 and VAX-D [32][33][34][35][36][37][38] , to our knowledge there is no published data available as to the efficacy of motorized spinal decompression delivered via SpineMED to individuals with neck pain secondary to herniated intervetebral disc. ...
... Other reports [32][33][34] have demonstrated improvements in visual analogue scale and/or in disability scales in patients with discogenic low back pain (LBP) after treatment with spinal decompression systems such as VAX-D and DRX9000. Although previous studies have reported that symptoms of acute and/or chronic LBP secondary to disc herniation might be relieved by intermittent axial decompression delivered via DRX9000 and VAX-D [32][33][34][35][36][37][38] , to our knowledge there is no published data available as to the efficacy of motorized spinal decompression delivered via SpineMED to individuals with neck pain secondary to herniated intervetebral disc. Therefore, the purpose of the present study was to determine the effect of the spinal decompression delivered via SpineMED combined with physical therapy modalities such as superficial heat, ultrasound, and interferential current (ICF) on the treatment of patients with cervical radiculopathy. ...
... Patients in the study reported statistically significant improvements in the mean measures of VAS and NDI after 20 sessions of treatment. Although there is no report in the literature on the efficacy of the intervention of a simultaneous combination of spinal decompression therapy and physical therapy modalities for patients with cervical radiculopathy, a combination of spinal decompression therapy and other treatment protocols has been shown to be beneficial for patients with discogenic LBP [32][33][34] . Patients with discogenic LBP demonstrated a significant improvement in VAS or disability scales such as the Oswestry Disability Index and the Roland-Morris Disability Questionaire after being treated with a combination of spinal decompression therapy and other treatment methods such as heat, cold, and transcutaneous electrical nerve stimulation. ...
[Purpose] The purpose of the present study was to determine the effect of a 4-week course of motorized spinal decompression delivered via SpineMED combined with physical therapy modalities on the treatment of patients with cervical radiculopathy (CRP). [Subjects] A total of 10 patients with CRP (mean age, 34.70 years; age range, 23-48 years) participated in the study. [Methods] A 4-week course of spinal decompression delivered via SpineMED combined with physical therapy modalities was delivered to the patients for 6 days per week for the first two weeks, and four times per week for two additional weeks. The entire treatment consisted of 20 visits over 4-week period. Comparisons of changes in the visual analogue scale (VAS) and neck disability index (NDI) at pre-intervention and at discharge were analyzed using the paired t-test. [Results] There was a significant improvement in the outcome measures of VAS and NDI after 20 sessions of spinal decompression combined with physical therapy modalities. The mean values of discharge for VAS and NDI were reduced by 21% and 14% respectively, as compared with their mean values at pre-intervention. [Conclusion] The results from the present study suggest that the use of motorized spinal decompression delivered via SpineMED combined with physical therapy modalities appears to be a safe and efficacious, noninvasive treatment modality for patients with CRP.
... Although it can be administered in many different forms, the overall goal of lumbar traction is to provide tensile forces parallel to the central long axis of the spine in an attempt to stretch soft tissues and reduce compressive loads acting upon the intervertebral disc (IVD) (Pellecchia, 1994). Currently, wide arrays of techniques are described for use in clinical environments (Clarke et al., 2006;Beattie et al., 2008). These techniques include various applications of manual traction and numerous types of machine-based interventions. ...
... Lumbar traction has, however, remained popular with patients. It is frequently associated with favorable anecdotal and case series reports suggesting that this intervention may be effective for a currently undefined subset of people with back pain (Beattie et al., 2008;Madson and Hollman, 2015). Thus, the overall clinical usefulness of lumbar traction remains uncertain. ...
Background:
Lumbar traction is a common treatment for low back pain; however its mechanisms of action are poorly understood. It has been hypothesized that a key effect of lumbar traction is its capacity to influence fluid movement within the intervertebral disc (IVD).
Objectives:
To determine differences in the apparent diffusion coefficient (ADC) obtained with lumbar diffusion-weighted imaging (DWI) of the L5-S1 IVD before, and during, the application of lumbar traction.
Design:
Case series, repeated measures.
Methods:
A static traction load of ∼50% of body-weight was applied to the low back using a novel "MRI-safe" apparatus. DWI of the lumbar spine was performed prior to, and during the application of the traction load.
Results:
Participants were currently asymptomatic and included a young adult group (n = 18) and a middle-aged group (n = 15). The young adult group had a non-significant 2.2% increase in ADC (mean change = 0.03 × 10(-3) mm(2)/s, SD = 0.24, 95% CI = -0.09, 0.15). The ADC for the middle-aged group significantly increased by 20% (mean change of 0.18 × 10(-3) mm(2)/s, SD = 0.19; 95% CI = 0.07, 0.28; p = 0.003; effect size = 0.95). There was an inverse relationship between the ADC obtained before traction and the percent increase in ADC that was measured during traction.
Conclusion:
Static traction was associated with an increase in diffusion of water within the L5-S1 IVDs of middle-age individuals, but not in young adults, suggesting age-related differences in the diffusion response. Further study is needed to assess the relationship between these findings and the symptoms of back pain.
Level of evidence:
4.
... Idiopathic scoliosis is a multifactorial, three-dimensional deformity of the spine and trunk that can appear and sometimes progress during any rapid growth period in apparently healthy children 1) . Adolescent idiopathic scoliosis (AIS) is the most common form and affects children. ...
... Traction-based therapies are non-invasive and probably cost-effective and have received interest recently 17) . For example, studies that have been reported that lacked a randomized comparison group 1,18) , had a retrospective design [19][20][21][22] , had sample that were small 19,20) , studied heterogeneous patient groups 31) or had authors who were commercially related to the evaluated therapy 20,21) . Moreover, there is still controversy within this particular field because various different traction techniques and corresponding protocols exists 23) . ...
Purpose] Traction-based therapies are non-invasive and probably cost-effective and have received in-terest recently. This study was conducted to compare two training programs, traction and stretching exercises, in rehabilitation of moderate scoliotic patients. [Subjects] Forty patients who were 15 to 25 years of age and had moderate scoliosis (Cobb's angle of 20 to 40 degrees) were randomized to either a stretching exercises group (n=20) or mechanical traction group (n=20). [Methods] All the patients were informed about the testing and training proce-dure and were allocated randomly into two groups. Both the groups received a common physical therapy program of 3 sessions a week for 3 months. In addition, the stretching exercises group received stretching of muscles on the concave side with postural instructions for activities of daily living. The mechanical traction group received me-chanical traction of the lumbar spine with postural instructions for activities of daily living. The outcome measures used were anteroposterior view of loading X-ray to detect any change in the Cobb's angle of the lower spine, tape measurement to detect forward flexion of the trunk by using fingertip-to-floor test (FFT), and the visual analogue scale (VAS) for pain measurement. [Results] There was more significant improvement of the Cobb's angle in the stretching exercises group than in the mechanical traction group. There was no significant difference in VAS and FFT values between the groups. [Conclusion] Stretching exercises led to significant improvement in the Cobb's angle and resulted in improvement of scoliotic curves in moderate scoliotic patients.
... Idiopathic scoliosis is a multifactorial, three-dimensional deformity of the spine and trunk that can appear and sometimes progress during any rapid growth period in apparently healthy children 1) . Adolescent idiopathic scoliosis (AIS) is the most common form and affects children. ...
... Traction-based therapies are non-invasive and probably cost-effective and have received interest recently 17) . For example, studies that have been reported that lacked a randomized comparison group 1,18) , had a retrospective design [19][20][21][22] , had sample that were small 19,20) , studied heterogeneous patient groups 31) or had authors who were commercially related to the evaluated therapy 20,21) . Moreover, there is still controversy within this particular field because various different traction techniques and corresponding protocols exists 23) . ...
... The results of the EG are superior to those of the CG. The lasting decrease in static and dynamic pain in patients from EG leads to increased mobility of the individuals, due to far less pain while being active (15,16). We relate the obvious superiority, regarding pain reduction, of the protocol used in EG with traction therapy's specific impact over the main causes of pain. ...
The goal of this research is to examine the efficiency of a set of physical factors with the inclusion of traction therapy in treating lumbar static and dynamic pain and the opportunities to influence the quality of life of patients with lumbar disc disease (LDD).100 patients with lumber disc disease participated in the clinical study. They were equally divided into a control group (CG), which has been treated with basic therapy (LFMF and IFC) and experimental group (EG) where traction therapy was part of the treatment protocol. For evaluating the effectiveness of the treatment was used quantitative assessment for static and dynamic pain and the quality of life before and after thetreatment. Results of both treatment protocols have statistically significant effect (p<0,001) in reducing low back pain and improving the quality of life. In comparison between the two groups, EG has a statistically significant (p<0,001) advantage over the CG. The inclusion of extension therapy in basic physical therapy gives excellent results, contributes to a more significant reduction ofpain and improves the quality of life of patients.
... Core Stabilization Exercise (CSE) also might be beneficial for patients with chronic LBP, CSE alone might not be sufficient for best improvement in patients with serious physical limitations to functional recovery [29]. It has been recommended that the combination of SDT and other treatment protocols would be useful for patients with discogenic LBP [2,20,9]. Al-Qudah & Al-Jazzazi [2] studied the effect of CM and modified SDT (Combined Lumbar Traction With Cervical Traction) with CSE in patients with Lumbar bulging disc, Significant improvement in pain and daily ability were found after 6 weeks. ...
Traction Is Part Of The Evidence Based Manual Physical Therapy Management Due To Its Mechanical Nature. The Efficacy Of Lumbar Traction (Lt) Has Been Established, Lt As The Most Used Method Of Spinal Decompression Therapy (Sdt) Reduces The Intradiscal Pressure And Vertically Increases The Intervertebral Space And Restore Disc Height Allowing Nutrients And Oxygen Supply To The Disc. While Lt Had Recently Been Used As A Conservative Treatment For Chronic Lumbar Disc Herniation (Cldh), Combined Lumbar Traction With Cervical Traction (Cltct) As One Intervention Which Has Been Suggested By (Al-Qudah, M.K) Was Used As A Part Of Rehabilitative Program In Patients With Cldh. Therefore, The Effectiveness Of Cltct Separately At Any Other Interventions Remains Absolutely Unclear And Uncertain. Objective: The Aim Of The Presented Work Is To Identify The Effectiveness Of Cltct [(Positional Sustained Lumbar Traction (Pslt) Combined With Mechanical Sustained Cervical Traction (Msct) As One Intervention] On Patients With Moderate (L4-L5) (L5-S1) Cldh, And To Compare Cltct With Traditional Mechanical Lumbar Traction (Mlt). Methods: In This Study, Twelve Outdoor Male Patients Diagnosed With Magnetic Resonance Imaging (Mri), Had Accepted To Participate The Study. They Were Chosen From Al-Karak Governmental Hospital, From 20th Of December To 1st February 2021. Subjects Were Divided Randomly In To Two Groups, Experimental Group (N=6) Performed Cupping Massage (Cm), Cltct And Core Stabilization Exercise (Cse), While The Control Group (N=6) Performed Cm, Mlt And Cse. All Subjects Were Advised To Perform The Cse Three Times Daily As A Home Program In Addition To One Set During Each Session Under The Therapist Supervision. All Subjects Had Exposed (18) Sessions For (6) Weeks. The Results Were Analyzed Using The Spss System. Results: Indicates That There Was Statistically Significant Difference Between The Pre And Post Measurements In Both Groups In Favor Of The Post Measurements In Term Of Pain And Disability. Also Results Indicate That There Was Statistically Significant Difference Between The Groups In Favor Of Experimental Group. Conclusions: The Present Study Demonstrates That The Use Of Cltct Has A Positive Effect On Patients With Cldh More Than Mlt.
... Spinal traction (ST) is a form of decompression therapy which was designed to relieve pressure on the spine and improve spinal alignment. Among the many beneficial effects of ST, its main aim is to provide pain relief, help achieve spinal alignment, and relieve pressure on nerves, particularly in patients with disc disease [1]. ...
Background: A standard spinal traction (ST) device was designed to straighten the spine without considering physiological lumbar lordosis. Using lordotic curve-controlled traction (LCCT), which maintains the lordotic curve during traction, the traction force would be applied to the posterior spinal structure effectively. Thus, the purpose of our study was to evaluate real-time biomechanical changes while applying the LCCT and ST. Methods: In this study, 40 subjects with mild non-radicular low back pain (LBP) were included. The participants underwent LCCT and ST in random order. Anterior and posterior intervertebral distance, ratios of anterior/posterior intervertebral distance (A/P ratio), and lordotic angles of intervertebral bodies (L2~L5) were measured by radiography. Results: Mean intervertebral distances were greater during LCCT than those measured prior to applying traction (p < 0.05). Mean A/P ratio was also significantly greater during LCCT than during ST or initially (p < 0.05). In particular, for the L4/5 intervertebral segment, which is responsible for most of the lordotic curve, mean LCCT angle was similar to mean lordotic angle in the standing position (10.9°). Conclusion: Based on measurements of radiologic geometrical changes with real-time clinical setting, the newly developed LCCT appears to be a useful traction device for increasing intervertebral disc spaces by maintaining lordotic curves.
... Back symptoms are frequently accompanied by depression or anxiety and psychological distress. 8,9 Hence; the present study was undertaken for assessing the prevalence of anxiety and depression among chronic low back pain patients. ...
... Although CSE might be beneficial for patients with chronic LBP, CSE alone might not be sufficient for best improvement in patients with serious physical limitations to functional recovery [6]. Regarding the addition of physical therapy modalities, it has been recommended that the combination of SDT and other treatment protocols would be useful for patients with discogenic LBP [12,21]. ...
Background:
Spinal decompression therapy (SDT) has recently been used as a conservative treatment for lumbar disc prolapse (LDP). The effectiveness of SDT when compared with other conservative techniques with a well-designed randomized controlled trials is lacking.
Objective:
To find the efficacy of SDT and core stabilization exercises (CSE) on pain and functional disability in individuals with chronic LDP, and to compare with CSE alone.
Methods:
This single blind randomized controlled trial included thirty-one participants with a mean age of 38.68 ± 8.79 having chronic LDP with or without radiating symptoms were included in the study. The study group received SDT with CSE and control group received CSE alone along with interferential therapy for both groups. Pain and disability were estimated by Numerical Rating Scale (NRS) and Modified Oswestry Questionnaire (mOQ).
Results:
The results demonstrated significant within-group improvements in all outcomes in both groups, the mean differences between pre to post intervention in SDT with CSE group were (NRS: 4.75, t= 12.81, p⩽ 0.001) and (mOQ: 45.13, t= 29.34, p⩽ 0.001), while in CSE group (NRS: 2.60, t= 13.67, p⩽ 0.001) and (mOQ: 27.67, t= 24.52, p⩽ 0.001).
Conclusions:
A combination of SDT with CSE has proven to be more significant when compared with CSE alone to reduce pain and disability in subjects with chronic LDP.
... Beattie and colleagues found that 84.4% of patients with low back pain, and with evidence of a degenerative and/or herniated intervertebral disc, reported significantly improved pain scores after 16 to 24 visits of prone traction at discharge and at 30 days and 180 days post-discharge [10]. ...
Background
Chronic pain has a negative impact on quality of life and psychological well-being. The objectives of this study are to investigate the psychological status and quality of life in backache patients before and after spinal traction and reflect how this maneuver is effective in treating backache.
Methods
Forty-seven backache patients completed the hospital anxiety and depression scale (HADS) and Short-Form 36 Health Survey (SF-36) before and after treatment with spinal traction. Forty-eight healthy controls, matched with patients for age and sex, completed the same questionnaires. Pain was assessed before and after the maneuver using a visual analog scale (VAS). Traction was added to patients’ medications which were not enough to control patients’ symptoms and did not change during the course of traction.
Results
Before spinal traction, the mean VAS score was 7 ± 1.36, abnormal levels of anxiety and depression were found in 36.17% and 40.43%, respectively, of patients, and all SF-36 domains of the study population, except for physical functioning, showed mean scores < 50%. After spinal traction, the mean VAS score dropped significantly to 5.44 ± 1.51, abnormal levels of anxiety and depression became 14.9% and 21.3%, and all SF-36 domains improved significantly, with six of the eight domains showing mean scores > 50%. There were significant differences regarding all SF-36 domains, and anxiety and depression scores between patients and controls, in favor of controls, before traction. These differences disappeared after spinal traction.
Conclusion
Pain, psychological status, and quality of life improved when spinal traction was added to medications reflecting its efficacy for patients with backache.
... There are conflicting results in randomized controlled trials conducted in recent years to assess the effectiveness of traction in reducing pain in patients with lumbar disc hernia [10][11][12][13][14] . These studies have been considered with suspicion because of the large number of treatment parameters and methodological faults 15 . ...
The aim of the study was to investigate the effects of 2 different traction loads on physical and clinical status in patients with subacute lomber disc hernia. Seventy patients were included in the study, and 9 of them withdrew their consent. Sixty-one patients were randomised. Patients in Group 1 (n=30) and 2 (n=31) received intermittent traction load of 35-50% and 10-20% of their body weights. Exercise program was demonstrated to both groups, and the patients were trained about prevention measures for low back pain. Treatment results of all patients were evaluated with visual analog scale, short-form 36, Oswestry Low Back Pain Disability Index, Roland Morris Disability Questionnaire before and in intragroup comparisons statistically significant difference was found before and after treatment, and also before and 40 days after treatment. While outcome evaluation scales revealed improvements in both groups (p>0.05). These results suggest that nearly half of the lumbar hernia patients can improve within about 2-6 weeks irrespective of the treatment, lomber hernia can benefit from physical therapy modalities and exercise other than lomber traction.
... The supine position is traditionally preferred during lumbar traction, 14,18 nonetheless, traction can also be effectively applied in the prone position. 13,21,22 Patient comfort and muscle relaxation during traction is considered essential to achieve the optimal effects of the intervention. 19, 22 Cyriax 23 postulated that lumber muscle relaxation was necessary to allow vertebral separation, which causes relief of "pinched" spinal nerves and reduction of protrusion. ...
Objective:
To compare the effects of mechanical lumbar traction either in the supine or prone position with conventional physical therapy(PT) in patients with chronic low back pain(LBP) and lumbosacral nerve root involvement in terms of disability, pain, and mobility.
Design:
Participants(n=125) were randomly assingned to receive 15 sessions of PT with additional mechanical lumbar traction either in the supine position(supine traction group), or in the prone position(prone traction group), or only PT without traction(PT only group).Patients were assessed at baseline and at the end of the PT sessions in terms of disability, pain, and mobility.Disability was assessed using the modified Oswesty Disability Index(ODI); pain was assessed using a visual analogue scale (VAS); and lumbar mobility was assessed using the modified lumbar Schober test (mLST).
Results:
118 patients completed the trial.All groups improved significantly in the ODI, VAS, and mLST(P<.05). In the between-group analysis, improvements of ODI and VAS were found significantly better in the prone traction group compared with the PT only group(adjusted P=.031 and .006, respectively).
Conclusion:
Addition of traction in prone position to other modalities resulted in larger immediate improvements in terms of pain and disability, and the results suggest that when using traction, prone traction might be first-choice.Further research is needed to confirm the benefits of lumbar traction in the prone position.
... 11,13) Studies showed that traction loading on the lumbar area of the spinal column should be approximately between 45% and 60% of the BW. 1,[14][15][16] In this study, firstly we used 45% and 55% of the BW as traction loading. Since the traction belt imposes the load on the L5 vertebra, we placed the load on L5 and fixed L1 in our model. ...
Background
The traction bed is a noninvasive device for treating lower back pain caused by herniated intervertebral discs. In this study, we investigated the impact of the traction bed on the lower back as a means of increasing the disc height and creating a gap between facet joints.
Methods
Computed tomography (CT) images were obtained from a female volunteer and a three-dimensional (3D) model was created using software package MIMICs 17.0. Afterwards, the 3D model was analyzed in an analytical software (Abaqus 6.14). The study was conducted under the following traction loads: 25%, 45%, 55%, and 85% of the whole body weight in different angles.
Results
Results indicated that the loading angle in the L3–4 area had 36.8%, 57.4%, 55.32%, 49.8%, and 52.15% effect on the anterior longitudinal ligament, posterior longitudinal ligament, intertransverse ligament, interspinous ligament, and supraspinous ligament, respectively. The respective values for the L4–5 area were 32.3%, 10.6%, 53.4%, 56.58%, and 57.35%. Also, the body weight had 63.2%, 42.6%, 44.68%, 50.2%, and 47.85% effect on the anterior longitudinal ligament, posterior longitudinal ligament, intertransverse ligament, interspinous ligament, and supraspinous ligament, respectively. The respective values for the L4–5 area were 67.7%, 89.4%, 46.6%, 43.42% and 42.65%. The authenticity of results was checked by comparing with the experimental data.
Conclusions
The results show that traction beds are highly effective for disc movement and lower back pain relief. Also, an optimal angle for traction can be obtained in a 3D model analysis using CT or magnetic resonance imaging images. The optimal angle would be different for different patients and thus should be determined based on the decreased height of the intervertebral disc, weight and height of patients.
... These results are due to the better effect of the experimental methodology in relation to the decrease of the dynamic pain, which lead to recovery of the motor activity and also related to the long-lasting of the psycho-emotional reserves. Our results demonstrating the potential of traction therapy in targeting pain syndrome matched those of other authors (13,14). ...
... A separate retrospective study by [36] also showed benefit with motorized spinal decompression over standard pelvic traction. [37] examined outcomes after administration of an 8-week course of VAX-D and noted significant improvements for all post-intervention outcome scores when compared with preintervention score. ...
Aim of the work: To assess the efficacy of CT-guided transforaminal epidural steroid injection (CT-TFESI) as compared to vertebral axial decompression (VAX-D), the combined effect of both and medical treatment in the management of acute lumbar disc herniation.
Patients and methods: Forty-eight patients complaining of low back pain (LBP) with radicular symptoms due to lumbar disc herniation (
... 28 Treating lumbar disk herniation and spinal stenosis patients successfully with conservative care is documented. [29][30][31][32] Chiropractic manipulation prior to spine surgery is appropriate. 14 ...
Purpose:
The purpose of this case series is to report on changes in pain levels experienced by 69 postsurgical continued pain patients who received Cox Technic Flexion Distraction (CTFD).
Methods:
Fifteen doctors of chiropractic collected retrospective data from the records of the postsurgical continued pain patients seen in their clinic from February to July 2012 who were treated with CTFD, which is a type of chiropractic distraction spinal manipulation. Informed consent was obtained from all patients who met the inclusion criteria for this study. Data recorded included subjective patient pain levels at the end of the treatments provided and at 24 months following the last treatment.
Results:
Fifty-four (81%) of the patients showed greater than 50% reduction in pain levels at the end of the last treatment, and 13 (19%) showed less than 50% improvement of pain levels at the end of active care (mean, 49 days and 11 treatments). At 24-month follow-up, of 56 patients available, 44 (78.6%) had continued pain relief of greater than 50% and 10 (18%) reported 50% or less relief. The mean percentage of relief at the end of active care was 71.6 (SD, 23.2) and at 24 months was 70 (SD, 25). At 24 months after active care, 24 patients (43%) had not sought further care, and 32 required further treatment consisting of chiropractic manipulation for 17 (53%), physical therapy, exercise, injections, and medication for 9 (28%), and further surgery for 5 (16%).
Conclusion:
Greater than 50% pain relief following CTFD chiropractic distraction spinal manipulation was seen in 81% of postsurgical patients receiving a mean of 11 visits over a 49-day period of active care.
... For the low force, the distraction tension was set as High force tension X 1/2 + 3.5 KG. The decompression started from a beginning force of zero KG and slowly built up to the maximum force [6]. Each workout must be increased 2-4 Lbs for women and 3-5Lbs for men, always based on the patient´s clinical status. ...
Background: Conservative care for degenerative spinal conditions includes several modalities of treatment. Thus, the traction distinguishes as it is capable to elicit the body´s protective proprioceptive response to distraction, reducing intradiscal pressure and minimizing symptoms secondary to disc herniation and axial pain.
Objectives: This work aims to determine the clinical effects of a short treatment course of motorized axial spinal decompression for patients with pain and physical impairment, caused from either lumbar or cervical degenerative disc pathology with no immediate surgical indication.
Methods: A prospective, non-randomized, single center, case series study from patients with both axial and irradiated symptoms from cervical or lumbar spine. Subjects were submitted to a traction protocol using a motorized mechanical axial decompression system (SpineMED®, LAS Brasil, SP). Clinical outcomes as VAS and ODI for lumbar patients 17 and NDI for cervical patients were also collected.
Results: Clinical outcomes improved along the treatment. AP-VAS scores showed an overall reduction of 59% (p<0.001), while IP-VAS scores improved in 56% in the last session (p<0.001). Average ODI showed statistical significance at last session (28 to 18; p=0.014). Average NDI also showed statistical significance at last session (30 to 20; p<0.001). Despite some minor adverse events, no major complication occurred during treatment.
Conclusion: This present spinal decompression treatment significantly improved patient’s clinical outcomes, indicating that this modality of treatment is a safe and effective noninvasive alternative for patients with cervical or lumbar axial pain and radiculopathy.
... In this study, the patients reported a significant improvement in the mean measures of pain level and functional activities after being treated in 20 sessions of combined treatment. These findings correlate well with those of Beattie et al. 41) and Macario et al. 42) as well as Gose et al. 43) who reported significant improvements in VAS and/ or a disability scale for patients with discogenic low back pain (LBP) after being managed with spinal decompression therapy in combination with other treatment modalities such as heat, cold, and transcutaneous electrical nerve stimulation. However, their study subjects were patients with discogenic LBP, not cervical radiculopathy, and the present study used a multimodal treatment approach as the intervention instead of a single specific treatment for the management of herniated disc. ...
[Purpose] The aim of the present study was to determine whether a multimodal treatment approach using spinal decompression via SpineMED and spinal mobilization as well as cervical stabilization exercises would benefit patients with neck pain with radiculopathy. [Subjects] A total of 10 patients with cervical radiculopathy ranging in age from 19 to 46 with an average age of 35.50 years participated in this study. [Methods] Patients received treatment in 85 minute sessions, 6 days per week for the first two weeks, and 4 days per week for two additional weeks. Treatment protocol consisted of spinal decompression via SpineMED and flexion-distraction mobilization of the cervical spine as well as cervical stabilization exercises. Physical therapy modalities including superficial heat, ultrasound, and interferential current were also delivered prior to administration of SpineMED. Differences between patients' pre-intervention and discharge outcome measures, pain on a visual analogue scale (VAS) and neck disability index (NDI), were examined using a paired t-test. [Results] Mean measures of patients' VAS and NDI demonstrated significant improvement after being treated with 20 sessions of combined treatment. [Conclusion] Findings of the present study provide significant evidence to support the efficacy of a multimodal treatment approach using spinal decompression via SpineMED and spinal mobilization as well as cervical stabilization exercises. A multimodal approach might be an asset in the management of cervical spine disorders.
... Lumbar herniated nucleus pulposus occurs most frequently in the lumbar spine and typically responds poorly to conventional traction treatment because insufficient traction power is delivered to the lumbar spine due to the contraction of the paravertebral muscles in a protective reflex 6) . Therefore, facilities that enable axial decompression therapy and that can produce sufficient traction power have recently been developed and utilized in clinics, and they have been reported to be effective for pain relief 7) . ...
[Purpose] The purpose of this study was to examine the effects of decompression therapy combined with joint mobilization on the pain and range of motion of patients with lumbar herniated nucleus pulposus. [Subjects] A total of 31 subjects were randomly assigned to an experimental group of 17 subjects and a control group of 14 subjects. [Methods] The experimental group received joint mobilization and decompression therapy, while the control group received thermotherapy, electrotherapy, and decompression therapy. Pain on visual analog scale (VAS) and the ranges of motion of flexion, extension, and lateroflexion were measured in both groups before the treatment and after the four weeks of treatment. [Results] Comparison of visual analog scale scores and the ranges of motion before and after treatment showed greater statistically significant differences in the experimental group than in the control group. [Conclusion] Decompression therapy combined with joint mobilization was effective as an intervention method for relieving pain and increasing the range of motion of the lumbar spine in patients with lumbar herniated nucleus pulposus.
... Generally, participants in this study demonstrated significant improvements in ODI and SLR after 10 and 20 sessions of spinal decompression treatment via DRX3000 apparatus combined with spinal mobilization and lumbar stabilization exercises. These results are consistent with findings of previous studies 29, 60,61) , which reported visual analog scale and/or a disability scale improvements for patients with discogenic LBP after treatment with spinal decompression therapy combined with other treatment protocols such as heat, cold, and/or muscle stimulation. ...
[Purpose] The purpose of this study was to determine the effects of motorized spinal decompression using the DRX3000 system (Axiom Worldwide, Tampa, FL, USA) combined with spinal mobilization as well as lumbar stabilization exercises on patients with discogenic low back pain (LBP). [Subjects] A total of 30 adults with discogenic LBP (mean age, 34.06 ± 6.41 years; age range, 28-48 years; 14 males, 16 females) volunteered to participate in this study. [Methods] A 4-week course of spinal decompression treatment combined with motorized flexion-distraction mobilization and lumbar stabilization exercises were administered to the participants for 6 days per week for the first two weeks, and four times per week for two additional weeks. The entire treatment consisted of 20 visits over a 4-week period. Comparisons of changes in the Oswestry Disability Index (ODI) and straight leg raise (SLR) test at pre-intervention, after 10 treatment sessions, and at discharge (after 20 treatment sessions) were analyzed. [Results] There were significant improvements in the outcome measures of ODI score and SLR test after 10 and 20 sessions of spinal decompression treatment combined with spinal mobilization and lumbar stabilization exercises as compared with the pre-intervention. [Conclusion] Spinal decompression treatment combined with spinal mobilization and lumbar stabilization exercises significantly improved the clinical outcome measures of ODI score and SLR test in patients with LBP secondary to intervertebral disc herniation.
... Beattie et al19 performed a prospective, longitudinal case series study involving 296 patients with low back pain and evidence of a degenerative andOrthopaedic & Sports Physical Therapy® Downloaded from www.jospt.org at on September 13, 2015. ...
The Orthopaedic Section of the American Physical Therapy Association (APTA) has an ongoing effort to create evidence-based practice guidelines for orthopaedic physical therapy management of patients with musculoskeletal impairments described in the World Health Organization’s International Classification of Functioning, Disability, and Health (ICF). The purpose of these low back pain clinical practice guidelines, in particular, is to describe the peer-reviewed literature and make recommendations related to (1) treatment matched to low back pain subgroup responder categories, (2) treatments that have evidence to prevent recurrence of low back pain, and (3) treatments that have evidence to influence the progression from acute to chronic low back pain and disability.
Low back pain is one of the biggest problems in modern world. Different physiotherapy programs are used for its treatment. Lumbar traction, has been used since the time of Hippocrates, but it is still the object of discussion. The purpose of this study was to determine the impact of traditional physiotherapy (control group), and traction therapy with TherapiMaster equipment (research group) on treatment of low back pain.
Subjects: 40 patients from 34 to 62 years of age with low back pain participated in the study. Methods: static and dynamic trunk muscle endurance, low back pain intensity (according to Numeric Rating Scale, and McGill pain questionnaire), and functional state (according to Roland-Morris questionnaire, and Oswestry disability index) of patients were evaluated. Patients of control group received 14 procedures of traditional physiotherapy. The patients in the research group received 14 procedures of lumbar traction with TerapiMaster equipment and exercises. Conclusions: Physiotherapy procedures improved static and dynamic trunk muscle endurance in both control and research groups (p < 0.01), reduced low back pain (p < 0.01), and improved the patients’ functional state in both groups (p < 0.01). The physiotherapy program with lumbar traction had better effect only relieving back pain assessed by McGill pain questionnaire compared to traditional physiotherapy (p < 0.05).
Keywords: low back pain, lumbar traction, physiotherapy, Roland-Morris and McGill questionnaires, Oswestry disability index.
. Aims. Low back pain (LBP) has become a global burden. Its prevalence among Africans is rising and is of concern. There is need to research in to methods of treating LBP and how to reduce disability from it. Method. A total number of 102 patients (31males and 71 females) with low back pain were purposely selected to participate in the study after obtaining their consent. The pain intensity of all the patients was assessed individually using Present Pain Intensity (PPI) on the first day pre test of their appointment in addition to other examinations. Roland-Morris Disability Questionnaire (RMDQ) was administered to all patients individually on the first day of report to the clinic and the score was noted. Prone traction technique was then administered to each patient twice in a week for 4 weeks making 8 treatment sessions. Pain intensity and disability were assessed again after 4 week using PPI and RMDQ (post test). The difference between the first score of RMDQ and the last score was calculated and the percentage of improvement was determined. Dependent-t test was used to compare the pre and post test values and an alpha level of 0.05 was set as level of significant. Results. Result revealed that there was a significant reduction in the mean value score of RMDQ when the pre and post test values were compared ( t= 15.74 p < .001). There was a significant reduction in the mean value of PPI at end of the 4th week ( t = 29.86, p <0.001). Also, there was a significant difference between mean value of percentage of improvement when comparing RMDQ of male and female (t = 5.89, P < 0.001). Conclusion. The study concluded that prone traction technique can be useful in ameliorating pain and disability of patients with low back pain.
Key words: prone traction technique, low back pain, disability questionnaire.
Objective:
This study compared the effects of high-force versus low-force lumbar traction in the treatment of acute lumbar sciatica secondary to disc herniation.
Methods:
A randomized double blind trial was performed, and 17 subjects with acute lumbar sciatica secondary to disc herniation were assigned to high-force traction at 50% body weight (BW; LT50, n = 8) or low force traction at 10% BW (LT10, n = 9) for 10 sessions in 2 weeks. Radicular pain (visual analogue scale [VAS]), lumbo-pelvic-hip complex motion (finger-to-toe test), lumbar-spine mobility (Schöber-Macrae test), nerve root compression (straight-leg-raising test), disability (EIFEL score), drug consumption, and overall evaluation of each patient were measured at days 0, 7, 1, 4, and 28.
Results:
Significant (P < .05) improvements were observed in the LT50 and LT10 groups, respectively, between day 0 and day 14 (end of treatment) for VAS (-44% and -36%), EIFEL score (-43% and -28%) and overall patient evaluation (+3.1 and +2.0 points). At that time, LT50 specifically improved in the finger-to-toe test (-42%), the straight-leg-raising test (+58), and drug consumption (-50%). No significant interaction effect (group-by-time) was revealed, and the effect of traction treatment was independent of the level of medication. During the 2-week follow-up at day 28, only the LT10 group improved (P < .05) in VAS (-52%) and EIFEL scores (-46%). During this period, no interaction effect (group-by-time) was identified, and the observed responses were independent of the level of medication.
Conclusions:
For this preliminary study, patients with acute lumbar sciatica secondary to disc herniation who received 2 weeks of lumbar traction reported reduced radicular pain and functional impairment and improved well-being regardless of the traction force group to which they were assigned. The effects of the traction treatment were independent of the initial level of medication and appeared to be maintained at the 2-week follow-up.
O uso da TENS para tratamento da espasticidade decorrente do acidente vascular encefálico (AVE) tem sido alvo de muitas pesquisas. O objetivo do trabalho é analisar por meio de uma revisão de literatura a eficácia da aplicação da TENS para a redução da espasticidade em pacientes após AVE. Realizada pesquisa em bancos de dados online (Medline/PubMed, Scielo e Lilacs) onde foram encontrados 58 artigos abordando o tema, porém apenas 10 se encaixaram nos critérios de inclusão, delimitados entre os anos de 2000 a 2014. Foi observada escassez de estudos que abordassem o tema, sendo verificado o emprego das mais variadas modalidades da TENS, indicando que a técnica é favorável na redução da espasticidade. A TENS parece confiável para reduzir a espasticidade decorrente do AVE, porém seus parâmetros ainda não foram bem estabelecidos. Assim, mais ensaios clínicos são necessários.
Introdução: A imagética motora (IM) tem sido proposta como forma de tratamento na síndrome de dor complexa regional tipo 1 (SDCR-1), pois parece promover um efeito de reorganização cortical nas áreas de percepção da dor. Objetivo: Investigar, a influência da IM sobre a SDCR-1, correlacionando suas evidências à prática clínica. Metodologia: Pesquisa nas bases de dados PEDro, Pubmed, Bireme e Scholar Google. Resultados: Na busca, foram encontrados 9 ensaios clínicos randomizados e controlados (nível 2), 1 estudo clínico não controlado (nível 3), 1 estudo de caso (nível 4), 1 estudo de revisão sistemática (nível 1), 2 artigos de revisão e 1 comentário (nível 5). Considerações finais: A IM tem apresentado efeito na diminuição da dor e no aumento da funcionalidade, que permanece após 6 meses do período de tratamento. Ainda é desconhecida a diferença entre as estratégias de IM (visual e cinestésica) na SDCR-1, bem como se a intensidade do esforço mental influencia na resposta dolorosa ou ainda o efeito da IM em outros tipos de neuropatias periféricas.
Background:
To date, no research has examined the reliability or predictive validity of manual unloading tests of the lumbar spine to identify potential responders to lumbar mechanical traction.
Purpose:
To determine: (1) the intra and inter-rater reliability of a manual unloading test of the lumbar spine and (2) the criterion referenced predictive validity for the manual unloading test.
Methods:
Ten volunteers with low back pain (LBP) underwent a manual unloading test to establish reliability. In a separate procedure, 30 consecutive patients with LBP (age 50·86±11·51) were assessed for pain in their most provocative standing position (visual analog scale (VAS) 49·53±25·52 mm). Patients were assessed with a manual unloading test in their most provocative position followed by a single application of intermittent mechanical traction. Post traction, pain in the provocative position was reassessed and utilized as the outcome criterion.
Results:
The test of unloading demonstrated substantial intra and inter-rater reliability K = 1·00, P = 0·002, K = 0·737, P = 0·001, respectively. There were statistically significant within group differences for pain response following traction for patients with a positive manual unloading test (P<0·001), while patients with a negative manual unloading test did not demonstrate a statistically significant change (P>0·05). There were significant between group differences for proportion of responders to traction based on manual unloading response (P = 0·031), and manual unloading response demonstrated a moderate to strong relationship with traction response Phi = 0·443, P = 0·015.
Discussion and conclusion:
The manual unloading test appears to be a reliable test and has a moderate to strong correlation with pain relief that exceeds minimal clinically important difference (MCID) following traction supporting the validity of this test.
Purpose] Traction-based therapies are non-invasive and probably cost-effective and have received interest recently. This study was conducted to compare two training programs, traction and stretching exercises, in rehabilitation of moderate scoliotic patients. [Subjects] Forty patients who were 15 to 25 years of age and had moderate scoliosis (Cobb's angle of 20 to 40 degrees) were randomized to either a stretching exercises group (n=20) or mechanical traction group (n=20). [Methods] All the patients were informed about the testing and training procedure and were allocated randomly into two groups. Both the groups received a common physical therapy program of 3 sessions a week for 3 months. In addition, the stretching exercises group received stretching of muscles on the concave side with postural instructions for activities of daily living. The mechanical traction group received mechanical traction of the lumbar spine with postural instructions for activities of daily living. The outcome measures used were anteroposterior view of loading X-ray to detect any change in the Cobb's angle of the lower spine, tape measurement to detect forward flexion of the trunk by using fingertip-to-floor test (FFT), and the visual analogue scale (VAS) for pain measurement. [Results] There was more significant improvement of the Cobb's angle in the stretching exercises group than in the mechanical traction group. There was no significant difference in VAS and FFT values between the groups. [Conclusion] Stretching exercises led to significant improvement in the Cobb's angle and resulted in improvement of scoliotic curves in moderate scoliotic patients.
Purpose] Traction-based therapies are non-invasive and probably cost-effective and have received in-terest recently. This study was conducted to compare two training programs, traction and stretching exercises, in rehabilitation of moderate scoliotic patients. [Subjects] Forty patients who were 15 to 25 years of age and had moderate scoliosis (Cobb's angle of 20 to 40 degrees) were randomized to either a stretching exercises group (n=20) or mechanical traction group (n=20). [Methods] All the patients were informed about the testing and training proce-dure and were allocated randomly into two groups. Both the groups received a common physical therapy program of 3 sessions a week for 3 months. In addition, the stretching exercises group received stretching of muscles on the concave side with postural instructions for activities of daily living. The mechanical traction group received me-chanical traction of the lumbar spine with postural instructions for activities of daily living. The outcome measures used were anteroposterior view of loading X-ray to detect any change in the Cobb's angle of the lower spine, tape measurement to detect forward flexion of the trunk by using fingertip-to-floor test (FFT), and the visual analogue scale (VAS) for pain measurement. [Results] There was more significant improvement of the Cobb's angle in the stretching exercises group than in the mechanical traction group. There was no significant difference in VAS and FFT values between the groups. [Conclusion] Stretching exercises led to significant improvement in the Cobb's angle and resulted in improvement of scoliotic curves in moderate scoliotic patients.
Patellofemoral pain (PFP) is one of the most common lower extremity conditions seen in orthopaedic practice. The mission of the second International Patellofemoral Pain Research Retreat was to bring together scientists and clinicians from around the world who are conducting research aimed at understanding the factors that contribute to the development and, consequently, the treatment of PFP. The format of the 2.5-day retreat included 2 keynote presentations, interspersed with 6 podium and 4 poster sessions. An important element of the retreat was the development of consensus statements that summarized the state of the research in each of the 4 presentation categories. In this supplement, you will find the consensus documents from the meeting, as well as the keynote addresses, schedule, and platform and poster presentation abstracts.
Thesis (M. Eng.)--Massachusetts Institute of Technology, Dept. of Materials Science and Engineering, 2008. Includes bibliographical references (leaves 36-40). Ferromagnetic shape memory alloys (FSMAs) are a new class of magnetic field-actuated active materials with no current commercial applications. By applying a magnetic field of around 0.4 T, they can exert a stress of approximately 1.5 MPa, exhibiting a strain of up to 6%. This thesis evaluates their technical and commercial feasibility in orthopaedic applications. Remote actuation is a key advantage FSMAs have over current implant materials. Also, the human body temperature is constant, providing a stable environment for FSMAs to operate. A number of potential orthopaedic applications are proposed and evaluated. Out of these, the most prominent application is the spinal traction device. It is a temporary implantable device, intended to perform internal spinal traction. A design has been proposed, with suggestions of suitable materials for its various components and appropriate device dimensions. Preliminary market and cost analyses have been conducted. This orthopaedic technology is currently in its infant stage. To commercialize this device, more trials are needed. by Weimin Guo. M.Eng.
Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person's body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (+/-25) to 32 (+/-27) with the IDD protocol and 53 (+/-26) to 36 (+/-27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.
Introduction. A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back pain. Methods. Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analysis was conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies. Developing Recommendations. An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required, but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established. Validating the Recommendations. A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%. Results. Four positive recommendations of clinical benefit were developed. Therapeutic exercises were found to be beneficial for chronic, subacute, and postsurgery low back pain. Continuation of normal activities was the only intervention with beneficial effects for acute low back pain. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 85%). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation), there was a lack of evidence regarding efficacy. Conclusions. This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing guidelines that incorporates clinicians' feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions for patients with low back pain where evidence was insufficient to make recommendations.
Study Design. A randomized clinical trial. Objectives. To assess the efficacy of motorized continuous traction for low back pain. Summary of Background Data. The available studies on the efficacy of lumbar traction do not allow clear conclusions because of severe methodologic flaws. The current trial aimed to overcome these shortcomings. Methods. Patients with at least 6 weeks of nonspecific low back pain were selected. High‐dose traction was compared with sham (or low‐dose) traction. Sham traction was given with a specially developed brace that becomes tighter in the back during traction. This was experienced as if real traction were exerted. The patients and the outcome assessor were unaware of treatment allocation. Outcome measures were: patient's global perceived effect, severity of main complaints, functional status, pain, range of motion, work absence, and medical treatment. Results for the outcome measures at 12 weeks and 6 months after randomization are presented. Results. One hundred and fifty‐one patients were randomly allocated to one of the two treatment methods. Intention‐to‐treat analysis of the 12‐week and 6‐month results showed no statistically significant differences between the groups on all outcome measures; all 95% confidence intervals included the value zero. The number of patients lost to follow‐up study was very low. Other analyses showed the same results. Conclusions. Most common flaws of earlier studies on traction therapy could be overcome. This trial did not support the claim that traction is efficacious for patients with low back pain.
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.
The measurement of subjective pain intensity continues to be important to both researchers and clinicians. Although several scales are currently used to assess the intensity construct, it remains unclear which of these provides the most precise, replicable, and predictively valid measure. Five criteria for judging intensity scales have been considered in previous research: (a) ease of administration of scoring; (b) relative rates of incorrect responding; (c) sensitivity as defined by the number of available response categories; (d) sensitivity as defined by statistical power; and (e) the magnitude of the relationship between each scale and a linear combination of pain intensity indices. In order to judge commonly used pain intensity measures, 75 chronic pain patients were asked to rate 4 kinds of pain (present, least, most, and average) using 6 scales. The utility and validity of the scales was judged using the criteria listed above. The results indicate that, for the present sample, the scales yield similar results in terms of the number of subjects who respond correctly to them and their predictive validity. However, when considering the remaining 3 criteria, the 101-point numerical rating scale appears to be the most practical index.
The purpose of this study was to conduct a systematic analysis of the literature to assess the efficacy of traction for patients with neck or back pain.
For this purpose, randomized clinical trials comparing traction with other treatments were selected.
A computer-aided search of the literature was conducted for relevant articles, followed by blinded assessment of the methods of the studies. The main outcome measures were (1) scoring for quality of the designated conduct of studies (based on a methodological checklist with four main categories: study population, interventions, measurement of effect, and data presentation) and the main conclusions of author(s) with regard to traction and (2) calculation of confidence intervals and power of the studies.
Only three studies scored more than 50 points (maximum score = 100 points), suggesting that most of the selected studies were of poor quality. None of these three studies showed favorable results for traction. Only four studies, of which one scored more than 50 points, had an acceptable power (1- beta > 80%).
The available reports of studies on the efficacy of traction for back and neck pain do not allow clear conclusions due to the methodological flaws in their design and conduct. Most studies lacked power (1-beta) due to small sample sizes. To date, no conclusions can be drawn about whether a specific traction modality for back or neck pain is effective, or more efficacious than other treatments. There are no clear indications, however, that traction is an ineffective therapy for back and neck pain. Further trials are needed in which much more attention should be paid to proper design and conduct, as well as to clear descriptions of crucial methodological features and results.
To estimate the importance and implications of placebo effects in pain treatment and research from the existing literature, with emphasis on their magnitude and duration, the conditions influencing them, and proposed explanations.
English-language articles and books identified through MEDLINE (1980 through 1993) and PsycLIT (1967 through 1993) database searching, bibliography review, and expert consultation.
Articles were included if they pertained to the review objectives.
Placebo response rates vary greatly and are frequently much higher than the often-cited one third. Placebos have time-effect curves, and peak, cumulative, and carryover effects similar to those of active medications. As with medication, surgery can produce substantial placebo effects, and this possibility is commonly overlooked in case series reports on back surgery. Individuals are not consistent in their placebo responses, and a placebo-responder personality has not been identified. Models advanced to explain placebo effects emphasize the role of anxiety, expectations, and learning.
Placebo effects influence patient outcomes after any treatment, including surgery, that the clinician and patient believe is effective. Placebo effects plus disease natural history and regression to the mean can result in high rates of good outcomes, which may be misattributed to specific treatment effects. The true causes of improvements in pain after treatment remain unknown in the absence of independently evaluated randomized controlled trials.
This study compared the ability of the Roland-Morris (RM), Oswestry (OSW), and Jan van Breemen Institute (JVB) pain and function questionnaires to detect change over time.
The sample consisted of 88 patients with mechanical low back pain who were referred by physicians to the outpatient physical therapy department of a teaching hospital.
Questionnaires were completed by the subjects at their initial visit and 4 to 6 weeks later. Clinically important change was estimated by having the subject and the clinician independently complete two rating scales. Sensitivity to change was assessed using receiver operating characteristic (ROC) curve analysis.
The ROC curve areas for the RM (0.79), OSW (0.78), and JVB pain (0.79) questionnaires were significantly greater than for the JVB function questionnaire (0.66). Blank and multiple responses per item were present on approximately 20% of the OSW questionnaires and 14% of the JVB questionnaires. Words rather than checks were evident on 3% of the RM questionnaires.
Based on the latter finding, we believe the RM questionnaire may be the preferred instrument for assessing change over time in patients with low back pain.
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Little is known about the usefulness of this instrument in aiding decision making regarding individual patients. The purpose of this study was to determine the minimum level of detectable change when the RMQ is applied to individual patients.
The study sample consisted of 60 outpatients with low back pain.
The RMQ was administered at the subjects' initial visit and again 4 to 6 weeks later. Conditional standard errors of measurement (CSEMs) were computed for initial and follow-up RMQ scores, and these values were used to estimate the minimum level of detectable change. Results. Minimum levels of detectable change at the 90% confidence level varied from 4 to 5 RMQ points.
The magnitude of CSEMs is sufficiently small to detect change in patients with initial scores in the central portion of the scale (4-20 RMQ points); however, the magnitude is too large to detect improvement in patients with scores of less than 4 and deterioration in patients who have scores greater than 20.
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.
A randomized clinical trial.
To assess the efficacy of motorized continuous traction for low back pain.
The available studies on the efficacy of lumbar traction do not allow clear conclusions because of severe methodologic flaws. The current trial aimed to overcome these shortcomings.
Patients with at least 6 weeks of nonspecific low back pain were selected. High-dose traction was compared with sham (or low-dose) traction. Sham traction was given with a specially developed brace that becomes tighter in the back during traction. This was experienced as if real traction were exerted. The patients and the outcome assessor were unaware of treatment allocation. Outcome measures were: patient's global perceived effect, severity of main complaints, functional status, pain, range of motion, work absence, and medical treatment. Results for the outcome measures at 12 weeks and 6 months after randomization are presented.
One hundred and fifty-one patients were randomly allocated to one of the two treatment methods. Intention-to-treat analysis of the 12-week and 6-month results showed no statistically significant differences between the groups on all outcome measures: all 95% confidence intervals included the value zero. The number of patients lost to follow-up study was very low. Other analyses showed the same results.
Most common flaws of earlier studies on traction therapy could be overcome. This trial did not support the claim that traction is efficacious for patients with low back pain.
EDITOR—In their survey of all randomised controlled trials published in 1997 in four major medical journals, Hollis and Campbell found that only 48% of the reports explicitly mentioned intention to treat analysis.1 In a considerable proportion it was insufficiently described and sometimes inadequately applied. Their results are confirmed by our assessment of all randomised controlled trials published between 1993 and 1995 in the same four journals.2 In addition to our assessment of ethical issues, …
Despite the widespread use of traction, little is known of the mode of effect, and application remains largely anecdotal. The efficacy of traction is also unclear because of generally poor design of the clinical trials to date, and because subgroups of patients most likely to benefit have not been specifically studied. These observations prompted this review, the purposes of which are to evaluate the mechanisms by which traction may provide benefit and to provide rational guidelines for the clinical application of traction. Traction has been shown to separate the vertebrae and it appears that large forces are not required. Vertebral separation could provide relief from radicular symptoms by removing direct pressure or contact forces from sensitised neural tissue. Other mechanisms proposed to explain the effects of traction (e.g. reduction of disc protrusion or altered intradiscal pressure) have been shown not to occur. We conclude that traction is most likely to benefit patients with acute (less than 6 weeks' duration) radicular pain with concomitant neurological deficit. The apparent lack of a dose-response relationship suggests that low doses are probably sufficient to achieve benefit.
The literature on the efficacy of traction in the treatment of low back pain (LBP) is conflicting. The aim of this study was to examine its efficacy in this disorder. Forty-two patients with at least 6 weeks of nonspecific LBP were selected. Demographic data were obtained. All patients completed the Oswestry disability index (ODI) to assess disability and the 10-cm visual analog scale (VAS) for evaluation of pain. Subjects were randomly assigned into group 1, receiving only standard physical therapy, or group 2, receiving standard physical therapy with conventional lumbar traction. Standard physical therapy consisted of local heat, ultrasound for the lumbar region, and an active exercise program, given for ten sessions in all. The subjects received instruction on correct posture and recommended therapeutic exercises. They were reevaluated at the end of treatment and at 3-month follow-up. The mean outcome measures were global improvement and satisfaction with the therapy, as well as disability by ODI and pain by VAS. There were no group differences in terms of demographic and baseline clinical characteristics. There was a significant reduction in pain intensity and disability at the end of treatment in both groups. There was complete or mild improvement in 47.6% of group 1 and 40% of group 2. The satisfaction rate with both treatments was more than 70% immediately after the therapies. During the 3-month period, the outcome measures except disability remained statistically stable, with no difference amongst groups. Disability was significantly reduced at follow-up in both groups. Of the patients, 51% continued with the recommended exercises and had significantly lower disability scores than those who did not continue with the exercises. Pain and global improvement were also better in this group, but the difference was not statistically significant. In conclusion, no specific effect of traction on standard physical therapy was observed in our study group. We suggest focusing on back education and exercise therapy in the management of patients suffering from this chronic condition.
Measurement properties of questionnaires should be based on samples of populations on whom these measurements will be used. The purpose of this study is to establish an evidence based recommendation regarding the use of functional status questionnaires in patients following a lumbar disc surgery by a direct comparison of the reproducibility and responsiveness.
The measurement properties of six functional status questionnaires were assessed: 1) Roland-Morris Disability Questionnaire (RDQ-24), 2) Modified Roland-Morris Disability Questionnaire (MRDQ), 3) short Roland-Morris Disability Questionnaire (RM-18), 4) Physical Functioning scale, 5) Role Limitations-Physical scale of the SF-36, and 6) The Main Complaint (MC). Subjects (n=97) that still suffered residual complaints 6 weeks following a lumbar disc surgery completed the questionnaires before and 3 months after treatment. In a direct comparison the A) The test-retest reproducibility (Intraclass Correlation Coefficients [ICC] and the Standard Error of Measurement [SEM]) and B) 3 parameters of responsiveness (Minimal Detectable Change [MDC], Standardised Response Mean [SRM], and the Area Under the receiver operator characteristic Curve [AUC]) were assessed.
This study suggests the superiority of the 3 versions of the RDQ compared to the 3 other questionnaires. Comparing the 3 versions of the RDQ reveals no substantial differences thereby indicating that the 2 modified version of the RDQ hold no better measurement properties in this specific population.
The use of the RDQ-24 for this specific post-surgery population is suggested. The optimal cut-off point of the RDQ-24 that minimizes the overall classification error was found to be 3.5 with a sensitivity of 94.6% and a specificity of 88.2%.
Systematic review.
To determine if traction is more effective than reference treatments, placebo/sham traction, or no treatment for low back pain (LBP).
Various types of traction are used in the treatment of LBP, often in conjunction with other treatments.
We searched MEDLINE, EMBASE, and CINAHL to November 2004, and screened the latest issue of the Cochrane Library (2004, issue 4) and references in relevant reviews and our personal files. We selected randomized controlled trials (RCTs) involving any type of traction for the treatment of acute (less than 4 weeks duration), subacute (4-12 weeks), or chronic (more than 12 weeks) nonspecific LBP with or without sciatica. Sets of 2 reviewers independently performed study selection, methodological quality assessment, and data extraction. Because available studies did not provide sufficient data for statistical pooling, we performed a qualitative "levels of evidence" analysis, systematically estimating the strength of the cumulative evidence on the difference/lack of difference observed in trial outcomes.
A total of 24 RCTs (2177 patients) were included. There were 5 trials considered high quality. For mixed groups of patients with LBP with and without sciatica, we found: (1) strong evidence that there is no statistically significant difference in short or long-term outcomes between traction as a single treatment, (continuous or intermittent) and placebo, sham, or no treatment; (2) moderate evidence that traction as a single treatment is no more effective than other treatments; and (3) limited evidence that adding traction to a standard physiotherapy program does not result in significantly different outcomes. For LBP with sciatica, we found conflicting evidence in several of the comparisons: autotraction compared to placebo, sham, or no treatment; other forms of traction compared to other treatments; and different forms of traction. In the remaining comparisons, there were no statistically significant differences; level of evidence is moderate regarding continuous or intermittent traction compared to placebo, sham, or no treatment, and is limited regarding different forms of traction.
Based on the current evidence, intermittent or continuous traction as a single treatment for LBP cannot be recommended for mixed groups of patients with LBP with and without sciatica. Neither can traction be recommended for patients with sciatica because of inconsistent results and methodological problems in most of the studies involved. However, because high-quality studies within the field are scarce, because many are underpowered, and because traction often is supplied in combination with other treatment modalities, the literature allows no firm negative conclusion that traction, in a generalized sense, is not an effective treatment for patients with LBP.
In a prospective study of 230 episodes of low-back pain presenting in primary care, the natural history of the symptom of low-back pain has been described. Clinical features predictive of outcome have been identified in order to define groups of patients who were relatively homogeneous with respect to the outcome of the episode. A Disability Questionnaire performed more satisfactorily as an outcome measure than either absence from work or a simple pain-rating scale. Guidelines for future trials of treatment of back pain in primary care are described.
running 20 billion dollars or more annually. (4,42) Total payments for a single Workman's Compensation claim may be as high as $100,000. Abenhain and Suissa studied the l-year incidence of work related low back pain in the province of Quebec for the year 1981. (1) Work absence due to back pain has an incidence of 1.4%. Seventy-four percent of work related injuries return to work within l month. 7.4% were out of work for more than 6 months. 75% of the direct total cost was borne by 10% of the absentees. Recurrence rates were 20% at l year and 36% after 3 years. Men had higher recurrence rates than women; drivers and nurses had higher recurrence rates than other occupations. The recovery rate of the Quebec workers is similar to other countries. After l year 4.3% remained absent from work. Incidence rates of compensated back injuries by industrial sector showed that foresters and miners are at the top with 4.9% and 3.3% respectively.
Objective.
—To estimate the importance and implications of placebo effects in pain treatment and research from the existing literature, with emphasis on their magnitude and duration, the conditions influencing them, and proposed explanations.
Data Sources.
—English-language articles and books identified through MEDLINE (1980 through 1993) and PsycLIT (1967 through 1993) database searching, bibliography review, and expert consultation.
Study Selection.
—Articles were included if they pertained to the review objectives.
Results.
—Placebo response rates vary greatly and are frequently much higher than the often-cited one third. Placebos have time-effect curves, and peak, cumulative, and carryover effects similar to those of active medications. As with medication, surgery can produce substantial placebo effects, and this possibility is commonly overlooked in case series reports on back surgery. Individuals are not consistent in their placebo responses, and a placebo-responder personality has not been identified. Models advanced to explain placebo effects emphasize the role of anxiety, expectations, and learning.
Conclusions.
—Placebo effects influence patient outcomes after any treatment, including surgery, that the clinician and patient believe is effective. Placebo effects plus disease natural history and regression to the mean can result in high rates of good outcomes, which may be misattributed to specific treatment effects. The true causes of improvements in pain after treatment remain unknown in the absence of independently evaluated randomized controlled trials.(JAMA. 1994;271:1609-1614)
The results of a prospective study of 134 patients with lower back pain suggest that nonorganic factors are better predictors of return to work than organic findings. Patients who returned to work had fewer job, personal, or family related problems. There were no significant differences between patients who returned to work and those who did not when comparing myelograms, computed tomographic scans, or roentgenographs. The only significant difference in physical organic findings was for muscle atrophy. Patients who did not return to work had a statistically higher incidence rate of muscle atrophy. Length of time off from work was significantly related to outcome, but when patients were categorized according to time off the job, different factors predicted failure to return for patients off work for less than 6 months and patients off for more than 6 months. For patients off for less than 6 months, important predictors were a high Oswestry score, history of leg pain, family relocation, short tenure on the job, verbal magnification of pain, reports of moderate to severe pain on superficial palpation, and positive reaction to a "sham" sciatic tension test. None of these was a significant predictor for the group off for more than 6 months. For the group off work for more than 6 months, previous injuries, and stability of family living arrangements were among the significant predictors not significant for the group off less than 6 months. Using 21 factors selected from a larger group of 92 factors, three statistically significant (P less than or equal to 0.001) predictive measures were developed. These measures predicted return to work for the total sample, and for the two subgroups (off more than, or less than 6 months) more accurately than did the total set of 92 factors.
Effect size measures were computed for a sample of 100 research studies published in four leading rehabilitation journals. The effect size measures were categorized as small, medium, or large according to established criteria. Analysis of the effect size measures revealed that the average treatment effect was in the medium range (0.69). Further data analysis exposed a statistically significant difference in mean effect size values across articles contained in the four rehabilitation journals. A regression analysis indicated that characteristics of the study design were not significant predictors of effect size values in the 100 studies. The interpretation of effect size measures in relation to statistical significance testing is discussed and the argument made that reporting measures of effect size will assist researchers in determining the sensitivity of experimental manipulations in rehabilitation research.
In a prospective study of 230 episodes of low-back pain presenting in primary care, the natural history of the symptom of low-back pain has been described. Clinical features predictive of outcome have been identified in order to define groups of patients who were relatively homogeneous with respect to the outcome of the episode. A Disability Questionnaire performed more satisfactorily as an outcome measure than either absence from work or a simple pain-rating scale. Guidelines for future trials of treatment of back pain in primary care are described.
One of the problems in mounting a trial of treatment of back pain is the lack of suitable outcome measures. This paper describes the development and validation of a questionnaire designed to measure selfrated disability due to back pain. The questionnaire is short, simple, sensitive, and reliable. It would be suitable for use in future trials of treatment. (C) Lippincott-Raven Publishers.
Visual analogue scales (VAS) of sensory intensity and affective magnitude were validated as ratio scale measures for both chronic and experimental pain. Chronic pain patients and healthy volunteers made VAS sensory and affective responses to 6 noxious thermal stimuli (43, 45, 47, 48, 49 and 51 degrees C) applied for 5 sec to the forearm by a contact thermode. Sensory VAS and affective VAS responses to these temperatures yielded power functions with exponents 2.1 and 3.8, respectively; these functions were similar for pain patients and for volunteers. The power functions were predictive of estimated ratios of sensation or affect produced by pairs of standard temperatures (e.g. 47 and 49 degrees C), thereby providing direct evidence for ratio scaling properties of VAS. Vas sensory intensity responses to experimental pain, VAS sensory intensity responses to different levels of chronic pain, and direct temperature (experimental pain) matches to 3 levels of chronic pain were all internally consistent, thereby demonstrating the valid use of VAS for the measurement of and comparison between chronic pain and experimental heat pain.
The object of this study was to examine the effect of vertebral axial decompression on pressure in the nucleus pulposus of lumbar discs. Intradiscal pressure measurement was performed by connecting a cannula inserted into the patient's L4-5 disc space to a pressure transducer. The patient was placed in a prone position on a VAX-D therapeutic table and the tensionometer on the table was attached via a pelvic harness. Changes in intradiscal pressure were recorded at resting state and while controlled tension was applied by the equipment to the pelvic harness. Intradiscal pressure demonstrated an inverse relationship to the tension applied. Tension in the upper range was observed to decompress the nucleus pulposus significantly, to below -100 mm Hg.
The outcomes of vertebral axial decompression (VAX-D) therapy for patients with low back pain from various causes are reported. Data was collected from twenty-two medical centers for patients who received VAX-D therapy for low back pain, which was sometimes accompanied by referred leg pain. Only patients who received at least ten sessions and had a diagnosis of herniated disc, degenerative disc, or facet syndrome, which were confirmed by diagnostic imaging, were included in this study; a total of 778 cases. The average time between the initial onset of symptoms and the beginning of this therapy was 40 months, and it was four months or more in 83% of the cases. The data contained the patients' quantitative assessments of their own pain, mobility, and ability to carry out the usual 'activities of daily living'. The treatment was successful in 71% of the 778 cases, when success was defined as a reduction in pain to 0 or 1, on a 0 to 5 scale. Improvements in mobility and activities of daily living correlated strongly with pain reduction. The causes of back pain and their relationship to this therapy are also discussed.
A cross-sectional study comparing the relationship of symptoms with anatomic impairment visible on lumbar magnetic resonance imaging in 408 symptomatic subjects.
To determine how various anatomic impairments, including the magnitude and location of nerve compression visible on lumbar magnetic resonance imaging, are associated with patient reports of pain, weakness, and dysesthesia.
Anatomic impairments of the intervertebral disc, radicular canal, and associated soft tissues are prevalent in people with and those without low back pain or lower extremity radiculopathy. This has led to confusion in differentiating between symptom generators and benign variation visible on lumbar magnetic resonance imaging. Recent literature has suggested that the presence of nerve compression is an important finding in the prediction of symptoms. However, the threshold for meaningful nerve compression has not been described.
In this study, 408 participants undergoing a diagnostic workup for low back pain, radiculopathy, and/ or completed a survey and pain drawing. Participants underwent standardized lumbar magnetic resonance imaging using a 1.5-T scanner. Two classification systems describing the spatial distribution of symptoms were developed. An additional system to quantify the magnitude of nerve and thecal sac compression was created. All systems were assessed for reliability, after which comparisons among variables were performed using Chi2 as well as simple and multiple logistic regression analysis.
The reliability coefficients for categorizing patients on the basis of pain drawing ranged from 0. 75 to 0.88. The S1-S2 segmental distribution was the most commonly reported location of symptoms, followed by L4-L5. The most common magnetic resonance imaging diagnosis was "unremarkable," followed by "disc impairment without nerve compression." Disc extrusion was present in 10.8% of participants. The reliability of classifying nerve compression visible on magnetic resonance imaging ranged from 0.27 to 1. Nerve compression was present in 37% of participants, and 18% had severe nerve compression. There were no significant associations between segmental distribution of symptoms and the presence of anatomic impairment. However, according to a collapsed classification scale, severe nerve compression and disc extrusion were predictive of pain distal to the knee (odds ratios, 2.72 and 3. 34). The self-report of weakness was associated mildly with severe nerve compression and disc extrusion, but not with other findings. Magnetic resonance imaging findings did not predict self-reports of dysesthesia.
The presence of disc extrusion and/or ipsilateral, severe nerve compression at one or multiple sites is strongly associated with distal leg pain. Mild to moderate nerve compression, disc degeneration or bulging, and central spinal stenosis are not significantly associated with specific pain patterns. Although segmental distributions of pain can be determined reliably from pain drawings, this finding alone is of little use in predicting lumbar impairment. The self-report of lower extremity weakness or dysesthesia is not significantly related to any specific lumbar impairments. [Key words: back pain, diagnosis, magnetic resonance imaging, nerve compression, pain drawing, pathology]
Since the release of acute low back pain management guidelines in 1994, little was known about the effect of these guidelines on clinical practice. The purpose of this study was to examine physical therapists' reported management of acute and subacute lumbar impairment.
One in 10 registered physical therapists who were randomly selected from southern Ontario, Canada, (n=454) and all registered physical therapists from northern Ontario (n=331) were surveyed.
In the questionnaire, case scenarios covered 3 areas related to the management of lumbar impairment: (1) physical examination, (2) treatment and recommendations, and (3) therapists' beliefs regarding its management.
Five hundred sixty-nine questionnaires were returned (response rate=72.5%). Only data obtained for therapists (n=274) whose weekly workload included more than 10% of people with lumbar impairment were used in the analysis. Overall, patient education, exercise, and electrotherapeutic and thermal modalities were the preferred interventions for acute lumbar impairment (symptom onset of less than 5 weeks) with or without sciatica, whereas exercise and work modification were preferred for subacute lumbar impairment (symptom onset of 5 weeks or longer). There was a trend of using electrotherapeutic and thermal modalities with uncertain effectiveness. Only 46.3% of the therapists agreed or strongly agreed that practice guidelines were useful for managing lumbar impairment.
Although the physical therapists surveyed, in general, followed the guidelines in managing acute lumbar impairment, they felt uncertain regarding the value of practice guidelines. Future research should focus on identifying effective treatment approaches and exploring the effectiveness of practice guidelines.
Low back pain is one of the most significant medical and socioeconomic problems in modern society. International guidelines call for evidence-based management for the pain and disability associated with musculoskeletal disorders. The purpose of this randomized controlled trial is to address the question of efficacy and appropriateness of vertebral axial decompression (VAX-D) therapy, a new technology that has been shown in clinical research to create negative intradiscal pressures, and has been shown to be effective in treating patients presenting with chronic low back pain (> 3 months duration) with associated leg pain. Successful outcome was defined as a 50% reduction in pain utilizing a 10 cm Visual Analog Pain Scale and an improvement in the level of functioning as measured by patient-nominated disability ratings. Patients were randomly assigned to VAX-D or to TENS which was used as a control treatment or placebo. The TENS treatment demonstrated a success rate of 0%, while VAX-D demonstrated a success rate of 68.4% (p < 0.001). A statistically significant reduction in pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D.
Reductions in low back pain and referred leg pain associated with a diagnosis of herniated disc, degenerative disc disease or facet syndrome have previously been reported after treatment with a VAX-D table, which intermittently distracts the spine. The object of this study was to use dermatomal somatosensory evoked potentials (DSSEPs) to demonstrate lumbar root decompression following VAX-D therapy. Seven consecutive patients with a diagnosis of low back pain and unilateral or bilateral L5 or S1 radiculopathy were studied at our center. Disc herniation at the L5-S1 level was documented by MRI or CT in all patients. All patients were studied bilaterally by DSSEPs at L5 and S1 before and after VAX-D therapy. All patients had at least 50% improvement in radicular symptoms and low back pain and three of them experienced complete resolution of all symptoms. The average pain reduction was 77%. The number of treatment sessions varied from 12 to 35. DSSEPs were considered to show improvement if triphasic characteristics returned or a 50% or greater increase in the P1-P2 amplitude was seen. All patients showed improvement in DSSEPs after VAX-D therapy either ipsilateral or contralateral to the symptomatic leg. Two patients showed deterioration in DSSEPs in the symptomatic leg despite clinically significant improvement in pain and radicular symptoms. Overall, 28 nerve roots were studied before and after VAX-D therapy. Seventeen nerve root responses were improved, eight remained unchanged and three deteriorated. The significance of DSSEP improvement contralateral to the symptomatic leg is emphasized. Direct compression of a nerve root by a disc herniation is probably not the sole explanation for referred leg pain.
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.
If you open any book about research design or statistics, you will see examples of studies in which 40 or 50 people are randomly assigned to a treatment and a control condition, tested at baseline, and then retested every week for the next 2 months. These texts then extol the virtues of being able to look at changes over time, and how the groups can be compared with regard to the pattern of change. Buried in a footnote (if it's mentioned at all) is a caveat that, in order to perform the analysis, we need complete data on all subjects. If even 1 data point is missing for a person, that subject must be dropped from consideration. Unfortunately, trial participants rarely read our textbooks, and do not know the importance of complete data. Consequently, they sometimes have second thoughts about continuing with the research (perhaps because of adverse effects); they may get tired of the necessity to complete a questionnaire a number of times or to come into the clinic on a weekly basis in order to have blood drawn; they may move out of town; or they may, of course, die before the study ends.
Whenever follow up data are incomplete, the researcher faces some major problems. Firstly, because fewer subjects have complete data than was originally planned for, …
To define the minimum clinically important difference (MCID) for the visual analog scale (VAS) of pain severity by measuring the change in VAS associated with adequate pain control.
The authors conducted a prospective, observational study. Adult emergency department (ED) patients with acute pain (<72 hours) were eligible. Patients rated their pain severity on a 100-mm VAS on presentation and at discharge. Patients were asked if they would accept any analgesic, then if they would accept a parenteral analgesic before treatment. At discharge, they were asked whether they had received adequate pain control.
The authors enrolled 143 patients (mean age, 36 years; 54% female). The mean decrease in VAS was -30.0 mm (95% confidence interval [CI] = -36.4 to -23.6) for the 116 of 143 (81%) patients with adequate pain control at discharge vs. -5.7 (95% CI = -11.2 to -0.3) for the 27 with inadequate pain control (p < 0.001). At discharge, the mean VAS was 31.3 mm for those with adequate pain control vs. 55.1 for those without. Mean VAS for the 114 of 143 patients who would accept any analgesics initially was 64.7 vs. 47.1 for the 29 reporting no analgesic need. Initially, 77 patients would accept parenteral analgesics (mean VAS = 72.5 mm).
A mean reduction in VAS of 30.0 mm represents a clinically important difference in pain severity that corresponds to patients' perception of adequate pain control. Defining MCID based on adequate analgesic control rather than minimal detectable change may be more appropriate for future analgesic trials, when effective treatments for acute pain exist.
To assess the efficacy of traction for patients with low back pain (LBP) with or without radiating pain, taking into account the clinical technique or parameters used.
A computer-aided search of MEDLINE, CINAHL, AMED, and the Cochrane Collaboration was conducted for randomized controlled trials (RCTs) in the English language, from 1966 to December 2001.
RCTs were included if: participants were over the age of 18 years, with LBP with or without radiating pain; the intervention group received traction as the main or sole treatment; the comparison group received sham traction or another conservative treatment; and the study used 1 of 4 primary outcome measures.
The study was conducted in 2 strands. Strand 1 assessed methodologic quality using a specific criteria list recommended by the Cochrane Back Review Group. The strength of the evidence was then rated using the Agency for Health Care Policy and Research system. Strand 2 applied further inclusion criteria based on recommended clinical parameters. One reviewer conducted the selection and data extraction.
Strand 1: 1 study scored 9 points (maximum score, 10 points); the other 12 scored between 0 and 3 points, indicating that most were of poor quality. Nine studies reported negative findings, but only 1 study was of a high quality. Three studies reported positive findings and 1 study was inconclusive. Strand 2: only 4 trials having low methodologic quality were included, 2 of which reported negative findings, and 2 positive findings.
The evidence for the use of traction in LBP remains inconclusive because of the continued lack of methodologic rigor and the limited application of clinical parameters as used in clinical practice. Further trials, which give attention to these areas, are needed before any firm conclusions and recommendations may be made.
Vertebral axial decompression (VAX-D) is a form of spinal traction that is widely promoted as an effective and safe treatment of degenerated and herniated lumbar intervertebral disks. Information targeted at the general public emphasizes that the treatment is completely risk-free. We describe a patient with a large lumbar disk protrusion who experienced sudden, severe exacerbation of radicular pain during a VAX-D therapy session. Follow-up magnetic resonance imaging of the lumbar region showed marked enlargement of the disk protrusion, and urgent microdiskectomy was required. To our knowledge, this is the first reported complication of VAX-D therapy. This case shows that VAX-D therapy has the potential to cause sudden deterioration requiring urgent surgical intervention.
It is now feasible to adopt an evidence-based approach when providing physical treatment for patients with chronic LBP. A summary of the efficacy of a range of physical treatments is provided in Table 1. The evidence-based primary care options are exercise, laser, massage, and spinal manipulation; however, the latter three have small or transient effects that limit their value as therapies for chronic LBP. In contrast, exercise produces large reductions in pain and disability, a feature that suggests that exercise should play a major role in the management of chronic LBP. Physical treatments, such as acupuncture, backschool, hydrotherapy, lumbar supports, magnets, TENS, traction, ultrasound, Pilates therapy, Feldenkrais therapy, Alexander technique, and craniosacral therapy are either of unknown value or ineffective and so should not be considered. Outside of primary care, multidisciplinary treatment or functional restoration is effective; however, the high cost probably means that these programs should be reserved for patients who do not respond to cheaper treatment options for chronic LBP. Although there are now effective treatment options for chronic LBP, it needs to be acknowledged that the problem of chronic LBP is far from solved. Though treatments can provide marked improvements in the patient's condition, the available evidence suggests that the typical chronic LBP patient is left with some residual pain and disability. Developing new, more powerful treatments and refining the current group of known effective treatments is the challenge for the future.
To identify the current use of traction and the types of patients, treatment parameters, and treatment modalities used in conjunction with traction.
Postal survey, with 4 sections: professional characteristics of respondent, current use of traction, patient selection, and treatment parameters.
Musculoskeletal outpatient departments (private and nonprivate practitioners).
Random sample (N=1491) of chartered physiotherapists in the UK who work in the management of low back pain (LBP).
Not applicable.
Descriptive analysis of information on current use and practice in applying traction.
A response rate of 83% (n=1239) was achieved; 41% (n=507) use lumbar traction, which is most commonly used in the management of subacute LBP patients presenting with nerve root symptoms. Treatment parameters were established for weights (5-60 kg), frequency (2-3 times weekly), and length of treatment (4 wk). In addition, traction is commonly used with other modalities (87%): mobilizations, advice, and exercise.
Survey results show the continued use of lumbar traction despite the recommendations of numerous guidelines. Results also clarify the types of patients and the parameters used in the application of traction.
Acute low back pain in adults. Clinical practice guideline no. 14. Rockville: Dept of Health and Human Services
- S Bigos
- O Bowyer
- G Braen
Bigos S, Bowyer O, Braen G, et al. Acute low back pain in adults. Clinical practice
guideline no. 14. Rockville: Dept of Health and Human Services; 1994. AHCPR Publication
No. 95-0642.
Textbook of orthopedic medicine Diagnosis of soft tissue lesions
- J Cyriax
Cyriax J. Textbook of orthopedic medicine. Vol 1: Diagnosis of soft tissue lesions.
London: Bailliere Tindall; 1981. p 484, 493-7.
Practice variations, treatment fads, rising disability. Do we need a new clinical research paradigm?
- R Deyo
Deyo R. Practice variations, treatment fads, rising disability. Do we need a new clinical
research paradigm? Spine 1993;18:2153-62.
Program in Physical Therapy
- Reprint Requests
- Paul Beattie
- Phd
- Pt
- Ocs
Reprint requests to Paul Beattie, PhD, PT, OCS, Program in Physical Therapy,
Dept of Exercise Science, Arnold School of Public Health, University of South Carolina,
Columbia, SC 29208, e-mail: pbeattie@gwm.sc.edu. 0003-9993/08/8902-00072$34.00/0
Textbook of orthopedic medicine
- Cyriax
Clinically important change in the visual analog scale after adequate pain control
- Lee