Does Clinician Treatment Choice Improve the Outcomes of Manual Therapy for Nonspecific Low Back Pain? A Metaanalysis

DOES CLINICIAN TREATMENT CHOICE IMPROVE THE OUTCOMES OF MANUAL THERAPY FOR NONSPECIFIC LOW BACK PAIN? A METAANALYSIS Peter Kent, GradDip(ManipPhysio),a Darryn Marks, MManipPhysio,b Warrick Pearson, MManipPhysio,c and Jenny Keating, PhDd

ABSTRACT Objective: The purpose of this study is to quantitatively compare outcomes for trials when treating clinicians did, or did not, have the discretion to decide on treatment technique. Methods: CINAHL, EMBASE, MEDLINE, the Physiotherapy Evidence Database, the Cochrane Controlled Trials register, reference list searching, and citation tracking were investigated. Ten randomized controlled trials (RCTs) of mobilization and manipulation for nonspecific low back pain (NSLBP) met the inclusion criteria. The effectiveness of manual therapy with and without clinician technique choice was assessed using descriptive statistics and metaanalysis for the outcomes of pain and activity limitation. Results: In approximately two thirds of the included RCTs, clinicians had choice of treatment technique. There were no systematic differences favoring results for RCTs that did allow clinician choice of treatment technique. Conclusions: Few quality studies are available, and conclusions on the basis of these data need to be interpreted with caution. However, allowing clinicians to choose from a number of treatment techniques does not appear to have improved the outcomes of these RCTs that have investigated the effect of manual therapy for NSLBP. If tailoring manual therapy treatment to NSLBP patients does positively impact on patient outcomes, this is not yet systematically apparent. (J Manipulative Physiol Ther 2005;28:312-322) Key Indexing Terms: Low Back Pain; Treatment Outcome; Classification; Manual Therapy

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ystematic reviews of the effectiveness of manual therapy for low back pain (LBP) have reached varying conclusions.1-6 The most recent systematic reviews have concluded that manual therapy offers some benefit over no intervention or sham intervention for LBP, but is no more effective than other therapies.7-11 a

Private practice, and PhD candidate in the School of Physiotherapy, La Trobe University, Melbourne, Victoria, Australia. b Consultant Physiotherapist, Barnsley District General Hospital, Barnsley, South Yorkshire, UK. c Private practice, Apsendale/Edithvale Physiotherapy, Melbourne, Victoria, Australia. d Senior lecturer, School of Physiotherapy, La Trobe University, Victoria, Australia. This study was supported by Faculty of Health Sciences (La Trobe University, Melbourne, Victoria, Australia), Joint Coal Board Health and Safety Trust (Australia), and the Musculoskeletal Physiotherapy Association (Victoria). No benefits in any form have been, or will be, received from a commercial party related directly or indirectly to the subject of the manuscript. Submit requests for reprints to: Peter Kent, GradDip(ManipPhysio), School of Physiotherapy, La Trobe University, Melbourne, Victoria 3086, Australia (e-mail: [email protected]). Paper submitted April 8, 2004; in revised form August 11, 2004. 0161-4754/$30.00 Copyright D 2005 by National University of Health Sciences. doi:10.1016/j.jmpt.2005.04.009

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These systematic reviews have summarized the findings of randomized controlled trials (RCTs). In the context of the widespread practice of manual therapy for LBP and anecdotal support for its use, Rosner12-14 has criticized both the generalizability of findings of manual therapy RCTs and the validity of conclusions of systematic reviews on the basis of summaries of these trials. In approximately 80% of LBP presentations in primary care, the diagnostic label of bnonspecific LBPQ (NSLBP) is currently thought to be the most accurate.15-17 Most primarycontact clinicians believe NSLBP is heterogenous (a number of subgroups), and treat NSLBP patients differently on the basis of that heterogeneity.18 If subgrouping does affect outcome and response to treatment, then NSLBP research that does not accommodate subgrouping may deliver a diluted estimate of treatment effects. If subjects belonging to one subgroup respond to a particular intervention (such as manual therapy), and those belonging to other subgroups do not, this may explain the prevalence of contradictory results in NSLBP research (because of differential sampling of these subgroups in heterogenous cohorts).19-23 If clinicians do not think that research has investigated cohorts that resemble the patients that they see, and if they think that interventions have been implemented in ways that do not resemble the ways in which they practice, they are

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likely to remain reserved about adopting recommendations on the basis of that research. Clinicians may also perceive that the research effort is not serving them well. Furthermore, if particular interventions are effective only for specific LBP subgroups, this effectiveness could be masked in the outcomes of heterogenous cohorts. This might lead to abandoning therapy that is effective for some people with the condition. Accommodation for NSLBP heterogeneity could occur in the selection of subjects recruited into RCTs, and in the discretion regarding treatment technique selection that is delegated to participating clinicians. The differential selection of trial subjects on the basis of a clinical profile that indicates their probability of responding to manual therapy is constrained by the paucity of validated criteria on which to make this decision. Although there is evidence of better patient outcomes in acute LBP when making interventions on the basis of the Delitto subgrouping system24 compared with clinical practice guideline-based interventions,25 those interventions were more than manual therapy and included exercise and traction. We are aware of only one paper that has developed an empirically based clinical prediction rule for responders to manual therapy. Flynn et al26 found that the presence of 4 of 5 variables (duration of symptoms b16 days, Fear Avoidance Beliefs Questionnaire work subscale b19, at least one hip with N358 of internal rotation, hypomobility in the lumbar spine, and no symptoms distal to the knee) increased the likelihood of success with spinal manipulation from 45% to 95% (positive likelihood ratio = 24.4). This prediction rule has been validated in a second sample but only for a single type of spinal manipulative technique. The research aim of this quantitative systematic review was to test the hypothesis that RCTs of manual therapy for NSLBP show a greater therapeutic effect when participating clinicians have discretion regarding treatment selection.

METHODS Search Strategy Comprehensive electronic search strategies were used and are available on request from the first author. Searches were performed through August 2003 across the contents of the following databases: CINAHL, EMBASE, MEDLINE, the Physiotherapy Evidence Database (PEDro), and the Cochrane Controlled Trials register. The search also included checking the reference lists of retrieved papers and of systematic reviews of LBP RCTs,1,5-9 and tracking the citations of included papers. This process identified 288 relevant reports. The titles and abstracts were independently screened for suitability for inclusion by 2 reviewers. After this screening, 65 full papers were retrieved and independently screened by 2 reviewers for suitability for

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inclusion. Several authors were contacted for additional information. Of these papers, 55 were excluded for the reasons shown in Appendix A.27-81 Finally, 10 RCTs met the inclusion criteria.82-92

Selection Criteria Inclusion criteria. Randomized controlled trials compared the effects of manual therapy (spinal manipulation or mobilization) to either a nontreatment control group or an alternative treatment. (Manipulative techniques were defined as techniques involving a high-velocity thrust, and mobilization techniques as low-velocity techniques.93) Trial participants had to be older than 18 years with NSLBP of any duration. Trials were only included if the effects of manual therapy could be partitioned from the effects of other types of therapy and if continuous outcome data for change in pain and/or activity limitation (disability) were reported. Because of a lack of translation resources, only trials published in the English language were included. Exclusion criteria. Trials of LBP were excluded for the following reasons: if associated with tumor, metastatic disease, systemic inflammatory conditions, infection, pregnancy, fracture, metabolic disorders, spondylolisthesis, or of LBP after surgery; data for NSLBP could not be discretely identified (eg, trials with combined results for back and neck complaints); manual therapy and comparison groups were significantly different for either pain or disability at baseline; there were insufficient data for a standardized mean difference (effect size) to be calculated for pain or activity limitation; or a PEDro quality rating of 3 or less.

Quality Assessment Using the PEDro quality rating scale,94 one of the authors rated each paper and subsequently checked the rating of each item with the rating concluded by 2 independent PEDro raters. PEDro raters are trained and assessed in accurate determination of the methodological score. Thus, 3 independent quality assessment checks using PEDro criteria were applied to each paper. Data are available on the reliability of the PEDro rating scale.95 Reviewers were not blind to authors, institution, or journal. Appendix B shows the quality item rating for each of the included trials.

Data Extraction Three reviewers independently extracted the following data from each paper using a standardized form: subject inclusion and exclusion criteria, number of subjects in each group, description of comparison interventions, frequency of intervention and follow-up, whether the clinicians were given treatment technique choice, outcome measures, and the data required to calculate effect sizes for all possible comparisons.

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The group means and SD were extracted for each comparison and each outcome measure (pain and activity limitation) if available. Group mean change scores were used when post-intervention means were not available.89 Where the SD was not provided,83,91 an estimate of the SD was calculated as either one quarter of the range of raw scores or one fifth of the scale width. Where only median scores were provided,83 these were used as a best estimate of mean scores. All the included trials that measured the effects on pain used a Visual Analogue Scale (VAS). All the included trials measured activity limitation using one or more of the Oswestry Disability Questionnaire,96,97 Roland-Morris Disability Questionnaire,98 and SF-36 (Physical Function subscale),99,100 except for one trial88 that used the MacDonald Disability Questions. All of these assessment instruments attempt to measure the same underlying construct of activity limitation. Davidson and Keating101 have shown that the Oswestry Disability Questionnaire, Roland-Morris Disability Questionnaire, and SF-36 (Physical Function subscale) display comparable responsiveness. These instruments have also been shown to be moderately associated, with correlations ranging from approximately 0.6 to 0.8.102-108 For the purposes of this systematic review, data derived using any of these instruments was treated as being comparable. Where a trial used more than one measure of activity limitation, we preferentially used Oswestry scores.101 When some comparisons in an RCT report were for measures on which groups were not equal at baseline,83,85 these comparisons were not included in the analysis. Because the included trials had postintervention assessments taken at varying periods, these were partitioned into short-term and long-term outcomes, using a method reported by Assendelft et al.8 Short term was arbitrarily defined as less than 3 weeks after the intervention. If a trial had multiple assessments during that period, the assessment closest to 3 weeks was used. Long term was defined as greater than 3 weeks after intervention, and the assessment closest to 3 months was used. If trial clinicians were able to choose from a range of manual therapy techniques and had discretion regarding the spinal level(s) to which these techniques were applied, the option btreatment choiceQ was rated as bYes.Q If the trial did not meet both of these criteria, this option was rated bNo.Q During the search, selection, and data extraction phases, disagreements between reviewers were resolved through consensus negotiation.

Calculating Trial Effects The mean and SD for each group, for each comparison, at each outcome period (if available), and for both outcome variables (if available) were entered into Cochrane Collaboration Revman (v4.2) software.109 This software was used to calculate effect sizes and perform

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(inverse variance) metaanalytic pooling.109 A random effects model was used for pooling because of the statistical heterogeneity of some data (Mantel-Haenszel method).110 Effect sizes were calculated using the difference between the mean of the experimental group and the mean of the control group, divided by the pooled SDs of both groups. Effect sizes were adjusted for small sample bias using the method recommended by Hedges and Olkin.111 An effect size is a unitless measure that allows comparison of effects across studies that have used different measurement tools. It is useful, for example, for comparing change in pain in 2 studies, one of which used an 8-point pain rating scale and the other that used a 100-mm VAS. Effect sizes from different studies can be statistically pooled to give a best estimate of the size of the effect of a particular intervention. In addition, comparisons can be made between the effect sizes of different interventions for the same condition. Cohen112 suggests that the following descriptors might be used as a guide to the magnitude of effect sizes: trivial (0.0), small (0.2), moderate (0.6), and large (1.2). In some RCTs, outcomes for a single manual therapy group were compared to a number of other therapies. The differences in observed effects may not satisfy the statistical assumption of independence required for metaanalysis.113 To accommodate for this,85-87,89 the sample size of the manual therapy group used in the effect size calculator was divided by the number of comparisons that were made. Tests were made for significant differences (with 95% confidence) between the point estimates of pooled effect size where clinicians could or could not exercise discretion in treatment selection.114

RESULTS Study Characteristics Appendix C shows the included trials, duration of symptoms at inception of trial, inclusion and exclusion criteria, sample sizes, intervention and control treatments, and outcome measures. Trials included clinicians from a number of professional disciplines, but there were too few trials to partition by profession. Clinicians were able to choose their preferred treatment in approximately two thirds (7/10) of the trials included in this review.

Quantitative Data Synthesis Fig 1 shows the trials, the therapies that were compared, the effect sizes for each comparison, and the trial quality ratings. Trials are partitioned into those where clinicians could or could not exercise discretion in treatment selection. There was diversity present in the data available for the metaanalysis. Some trials compared manual therapy to no intervention or sham intervention, and some trials compared manual therapy to a variety of other interventions.

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Fig 1. Effect of manual therapy for NSLBP. When these data were analyzed using only the studies that compared manual therapy to no intervention/sham intervention, there was a significant difference between the pooled estimates of effect size for short-term activity limitation (difference = 0.62 F 0.47, z = 2.60, P = .00), in favor of the RCTs where clinicians did not have treatment technique choice. There were no significant differences between the pooled estimates of effect size for short-term pain and both long-term outcomes. These data were reanalyzed using only the studies that compared manual therapy to other interventions. There was a significant difference between the pooled estimates of effect size for both short-term pain (difference = 0.51 F 0.47, z = 2.13, P = .02) and short-term activity limitation (difference = 0.62 F 0.47, z = 2.60. P = .00), in favor of the RCTs where clinicians did not have treatment technique choice. There were no significant differences between the pooled estimates of effect size for both long-term outcomes. All the data were also analyzed collectively. There was a significant difference between the pooled estimates of effect size for both short-term pain (difference = 0.39 F 0.37, z = 2.04, P = .02) and short-term activity limitation (difference =

0.62 F 0.47, z = 2.60, P = .00), in favor of the RCTs where clinicians did not have treatment technique choice. There were no significant differences between the pooled estimates of effect size for both long-term outcomes, and this was unchanged when the analysis was repeated without the outlier in the data provided by Herzog et al.84 Whether statistically significant or not, all of the pooled estimates of effect size favored the RCTs where clinicians did not have treatment technique choice. This held across all 4 analyses.

DISCUSSION There is insufficient data available to definitively quantify the effect of clinician treatment choice on the results of RCTs of manual therapy for LBP. This would require larger numbers of high quality RCTs with similar comparisons. Therefore, the results of this review should be interpreted with caution. This is particularly so in the long-term outcome comparisons because there was only one RCT available for inclusion in the bYes-treatment choiceQ group. However, the

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Fig 1. (continued) limited data available do not provide support for a hypothesis that RCTs of manual therapy for NSLBP show a greater therapeutic effect when participating clinicians have discretion regarding treatment selection. If NSLBP is heterogenous and tailoring manual therapy treatment to NSLBP subgroups does positively impact on patient outcomes, the outcomes of the RCTs in this review do not reflect this. There could be a number of reasons for this result. It may be that tailoring manual therapy to NSLBP subgroups does positively impact on patient outcomes, but that there is insufficient consensus as to which subgroups respond to particular manual therapy interventions for consistent effects to become apparent across trials. Our survey data indicate little consensus within and between primary-contact professional disciplines regarding the specific signs and symptoms representative of putative NSLBP subgroups.115 This may have been compounded by the diversity of manual therapy techniques used in the RCTs included in this review. Alternatively, it may be that tailoring treatment to NSLBP subgroups has limited impact on patient outcomes because patients respond similarly regardless of manual therapy technique. A recent RCT found that there was no difference in within-treatment–session change in pain and

physical impairment depending on whether the mobilization technique used in NSLBP was btherapist selectedQ or brandomly selected.Q116 If clinicians and researchers are to continue to investigate the effectiveness of manual therapy for NSLBP, there are a number of strategies that might enhance the research yield. One strategy would be for future RCTs to proceed only after there is consensus regarding appropriate outcome measures and time intervals for reassessment. This would facilitate comparisons between studies and improve confidence that pooling of data across studies is sensible. Another strategy would be for RCTs to commence when there is greater clarity regarding the clinical profiles of patients who are likely to respond to manual therapy. Though not the primary aim of this study, it was noted that the preintervention inclusion and exclusion criteria of most of the included RCTs screened subjects only to ensure that they had NSLBP. In their inclusion criteria, Triano et al90 included bpalpatory tenderness over facet jointsQ, and Andersson et al82 included ba lesion suitable for manipulationQ as determined by osteopathic examination but using criteria not specified in the paper. These selection criteria could be refined using prospective inception cohort studies26

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that provide valid empirically based prediction rules for profiling patients’ likelihood of response to specific manual therapies. These studies can occur in a bsigns and symptomsQ paradigm,20,24-26,45 or in a pathoanatomically based paradigm.117-119 Ideally, prediction rules on the basis of prospective inception cohort studies will be retested in independent samples and will cover a range of manual therapy techniques.

Strengths and Weaknesses of this Review Strengths of the current study are that the review search was comprehensive and quantitative analysis was performed. There are a number of weaknesses of the current study. The interventions studied are mostly a single form of intervention, and the clinical effects of manual therapy combined with other interventions were not investigated. The generalizability of these findings to clinical situations of combined therapy is unknown. Furthermore, there was diversity in the data used for this metaanalysis because of the heterogeneity of comparisons, time intervals, and activity limitation outcome measures. This reduces the clinical interpretability of the point estimates of pooled effect size. In addition, the literature search was restricted to studies published in the English language, so cultural bias and publication bias cannot be excluded. Lastly, there is a small number of RCTs included in this study because of requirement of high quality usable data. Some impact of the bstainless steelQ law of systematic reviews, that is, bthe more rigorous the review, the less evidence there will be that the intervention is effective,Q120 cannot be excluded.

CONCLUSION The limited available evidence does not suggest that allowing participating clinicians’ discretion regarding technique selection has improved outcomes in RCTs of manual therapy for NSLBP. If NSLBP is heterogenous and tailoring treatment to NSLBP subgroups does positively impact on patient outcomes, this is not yet systematically observable. This may be because of limitations in the design of previous RCTs or because tailoring manual therapy treatment to NSLBP subgroups actually has minimal effect on pain and activity limitation. A direction for future research is to select patients for manual therapy RCTs with a clinical profile that indicates a likelihood of responding to manual therapy. If such a clinical profile exists, it could be identified using prospective inception cohort studies.

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without physical therapy and chiropractic care with and without physical modalities for patients with low back pain: 6-month follow-up outcomes from the UCLA low back pain study. Spine 2002;27:2193 - 204. 63. Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GM, Hofhuizen DM, et al. The effectiveness of manual therapy, physiotherapy, and treatment by the general practitioner for nonspecific back and neck complaints. A randomized clinical trial. Spine 1992;17:28 - 35. 64. Kokjohn K, Schmid DM, Triano JJ, Brennan PC. The effect of spinal manipulation on pain and prostaglandin levels in women with primary dysmenorrhea. J Manipulative Physiol Ther 1992;15:279 - 85. 65. Mannion AF, Muntener M, Taimela S, Dvorak J. Comparison of three active therapies for chronic low back pain: results of a randomized clinical trial with one-year follow-up. Rheumatology 2001;40:772 - 8. 66. Mathews JA, Mills SB, Jenkins VM, Grimes SM, Morkel MJ, Mathews W, et al. Back pain and sciatica: controlled trials of manipulation, traction, sclerosant and epidural injections. Br J Rheumatol 1987;26:416 - 23. 67. Meade TW, Dyer S, Browne W, Townsend J, Frank AO. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. BMJ 1990; 300:1431 - 7. 68. Nwuga VC. Relative therapeutic efficacy of vertebral manipulation and conventional treatment in back pain management. Am J Phys Med 1982;61:273 - 8. 69. Ongley MJ, Klein RG, Dorman TA, Eek BC, Hubert LJ. A new approach to the treatment of chronic low pain. Lancet 1987;2:143 - 6. 70. Postacchini F, Facchini M, Palieri P. Efficacy of various forms of conservative treatment in low back pain: a comparative study. Neuro-Orthop 1988;6:28 - 35. 71. Rasmussen GG. Manipulation in the treatment of low back pain — a randomized clinical trial. Man Med 1979:8 - 10. 72. Rupert RL, Wagnon R, Thompson P, Ezzeldin MT. Chiropractic adjustments: results of a controlled clinical trial in Egypt. Int Rev Chir 1985:58 - 60. 73. Sanders G, Tepe R, Maloney P, Reinert O. The effect of spinal adjustive manipulation on subjects with acute low back pain: a comparison of visual analog pain scores and serum beta endorphin levels. Symposium of the Pacific Consortium for Chiropractic Research, Monterey, California; July 2, 1989. J Manipulative Physiol Ther 1990:58. 74. Sims-Williams H, Jayson MI, Young SM, Baddeley H, Collins E. Controlled trial of mobilisation and manipulation for patients with low back pain in general practice. BMJ 1978;2:1338 - 40. 75. Sims-Williams H, Jayson MI, Young SM, Baddeley H, Collins E. Controlled trial of mobilisation and manipulation for low back pain: hospital patients. BMJ 1979;2: 1318 - 1320. 76. Jayson MI, Sim-Williams H, Young S, Baddeley H, Collins E. Mobilization and manipulation for low-back pain. Spine 1981;6:409 - 16. 77. Skargren EI, Oberg BE, Carlsson PG, Gade M. Cost and effectiveness analysis of chiropractic and physiotherapy treatment for low back and neck pain. Six-month follow-up. Spine 1997;22:2167 - 77. 78. Waterworth RF, Hunter IA. An open study of diflunisal, conservative and manipulative therapy in the management of acute anical low back. N Z Med J 1985;98:372 - 5. 79. Wreje U, Nordgren B, Aberg H. Treatment of pelvic joint dysfunction in primary care — a controlled study. Scand J Prim Health Care Suppl 1992;10:310 - 5.

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80. Zylbergold RS, Piper MC. Lumbar disc disease: comparative analysis of physical therapy treatments. Arch Phys Med Rehabil 1981;62:176 - 9. 81. Cherkin DC, Deyo RA, Battie M, Street J, Barlow W. A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain. N Engl J Med 1998;339:1021 - 9. 82. Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med 1999;341:1426 - 31. 83. Gibson T, Grahame R, Harkness J, Woo P, Blagrave P, Hills R. Controlled comparison of short-wave diathermy treatment with osteopathic treatment in non-specific low back pain. Lancet 1985;1:1258 - 61. 84. Herzog W, Conway PJ, Willcox B. Effects of different treatment modalities on gait symmetry and clinical measures for sacroiliac joint patients. J Manipulative Physiol Ther 1991;14:104 - 9. 85. Hsieh CY, Phillips RB, Adams AH, Pope MH. Functional outcomes of low back pain: comparison of four treatment groups in a randomized controlled trial. J Manipulative Physiol Ther 1992;15:4 - 9. 86. Hsieh CJ, Adams AH, Tobis J, Hong C, Danielson C, Platt K, et al. Effectiveness of four conservative treatments for subacute low back pain: a randomized clinical trial. Spine 2002;27:1142 - 8. 87. Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, et al. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine 2003;28: 1355 - 62. 88. MacDonald R, Bell C. An open controlled assessment of osteopathic manipulation in nonspecific low-back pain. Spine 1991;15:364 - 70. 89. Pope MH, Phillips RB, Haugh LD, Hsieh CY, MacDonald L, Haldeman S. A prospective randomized three-week trial of spinal manipulation, transcutaneous muscle stimulation, massage and corset in the treatment of subacute low back pain. Spine 1994;19:2571 - 7. 90. Triano JJ, McGregor M, Hondras MA, Brennan PC. Manipulative therapy versus education programs in chronic low back pain. Spine 1995;20:948 - 55. 91. Waagen GN, Haldeman S, Cook G, Lopez D, DeBoer KF. Short term trial of chiropractic adjustments for the relief of chronic low back pain. Man Med 1986;2:63 - 7. 92. Kinalksi R, Kuwik W, Pietrzak D. The comparison of the results of manual therapy versus physiotherapy methods used in treatment of patients with low back pain syndromes. Man Med 1989;4:44 - 6. 93. Maitland G. Vertebral manipulation. 5th ed. London (England)7 Butterworth-Heinemann; 1986. 94. TPED (PEDro). Sydney: centre for evidence based physiotherapy. Available from: http://www.pedro.fhs.usyd.edu.au [Accessed June 10, 2003]. 95. Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins A. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther 2003;83:713 - 21. 96. Baker D, Pynsent P, Fairbank J. The Oswestry Disability Index revisited: its reliability, repeatability and validity, and a comparison with the St Thomas’s Disability Index. In Roland MO, Jenner JR, editors. Back pain: new approaches to rehabilitation and education. Manchester7 Manchester Univ Press, 1989. p. 174 - 86. 97. Fairbank JC, Couper J, Davies JB, O’Brien JP . The Oswestry low back pain disability questionnaire. Physiotherapy 1980; 66:271 - 3.

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APPENDIX A. REASONS FOR EXCLUSION OF POTENTIAL PAPERS Potential paper Arkuszewski27 Aure et al28 Bergquist-Ullman and Larsson29 Blomberg et al30-33 Brennan et al34 Bronfort et al35 Buerger 36 Cherkin et al80 Cibulka et al38 Cibulka et al37 Cote and Mior et al,39 Cote et al40 Coxhead41 Coxhead et al42 Coyer and Curwen43 Cramer et al44 Delitto et al45 Doran and Newell46 Dutro and Meeker et al47 Edwards48 Erhard et al49 Evans et al50 Farrell and Twomey 51 Gemmell and Jacobson52 Gemmell and Jacobson53 Giles and Muller 54 Glover et al55 Godfrey et al56 Hadler et al57 Hawk et al58 Helliwell and Cunliffe59 Hemmila et al60 Hoehler et al61 Hurwitz et al62 Kinalksi et al91 Koes et al63 Kokjohn et al64 Mannion et al65 Mathews et al66 Meade et al67 Nwuga68 Ongley et al69 Postacchini et al70 Rasmussen71 Rupert et al72 Sanders et al73 Sims-Williams et al,74,75 Jayson et al76 Skargren et al77 Waterworth and Hunter78 Wreje et al79 Zylbergold80

Reasons for exclusion A B A A, B C A C A C B A C B C A A C A C A C C A A B C A A C C A C A A B B A B, C A B A C C C C A A A D A

A, The effects of manual therapy could not be partitioned from the effects of other types of therapy; B, not NSLBP; C, no measures of pain or activity limitation in a form suitable for calculation of effect size; D, groups not comparable at baseline.

Y Y Y Y Y Y Y Y Y Y

Andersson et al,82 7/10 Gibson et al,83 4/10 Herzog et al,84 4/10 Hsieh et al,85 4/10 Hsieh et al,86 8/10 Licciardone et al, 87 6/10 MacDonald and Bell,88 5/10 Pope et al,89 6/10 Triano et al,90 6/10 Waagen et al,91 5/10 Y Y Y Y Y Y Y Y Y Y

Random allocation Y N N N Y Y N N Y N

Concealed allocation N Y Y N Y Y Y Y Y Y

Baseline comparison N N N N N N N N N N

Blind subjects N N N N N N N N N N

Age, 20-59 y; manipulation warranted (osteopathic decision); duration, 3-26 wk

NSLBP

NSLBP

LBP and sacroiliac dysfunction

NSLBP

Andersson et al82

Gibson et al83

Herzog et al84

Hsieh et al85

Age, 18-50 y; diagnosed independently as SIJ problem by 2 clinicians; onset unrelated to trauma; duration, N4 wk Age, 18-55 y; self-reported good health; duration, 3-26 wk

Duration, 8-52 wk

Inclusion criteria

Condition

RCT

Nerve compression, fracture, tumor infections, spondyloarthropathy, Not overweight (Davenport index), previous manipulative therapy for this episode, previous back surgery, heart pacemaker, compensation or insurance issues

Nerve compression, inflammatory, metabolic or neoplastic spinal disease, spondylolysis, spondylolisthesis, LBP medication other than analgesia Extreme obesity, nonambulatory

Nerve compression, systemic inflammatory conditions, scoliosis, serious medical illnesses, substance abuse, mental illness, pregnancy, litigation, workers’ compensation, manipulated within 3 wk

Exclusion criteria

APPENDIX C. CHARACTERISTICS OF INCLUDED TRIALS

Diversified chiropractic manipulation to lumbar spine and/or SIJ + hot pack (n = 26)

Manipulative therapy (n = 16)

Manipulation, mobilization and soft tissue techniques (n = 41)

Manipulation, muscle energy, counterstrain, articulation, myofascial release, plus 10-min back pain video (n = 83)

Intervention procedure (sample n)

Y Y Y Y Y N N Y Y Y

Blind assessor Y N N N Y N Y Y N N

N N N N Y N N N N N

ITT analysis

(1) Gentle stroking massage + hot pack (n = 15); (2) corset (n = 12); (3) TMS (n = 10)

Back school (n = 13)

Standard medical care (analgesics, NSAID, active but not manual physiotherapy, ultrasound, diathermy, hot/cold packs, corset, TENS plus 10-min back pain video) (n = 72) (1) Short wave (n = 34), (2) detuned short wave (n = 34)

Control procedure and (sample n)

Adequate follow-up

No—rotation manipulation only, but levels to be treated chosen by clinician (9 treatments over 3 wk)

Yes—at clinician discretion (up to 10 treatments over 4 wk)

Yes—at clinician discretion (4 treatments over 4 wk)

Yes—clinicians treating both groups could choose technique(s) (8 treatments over 12 wk)

Treatment choice (treatment frequency)

Blind therapist

ITT, intention to treat. T The item beligibility criteriaQ relates to the generalizability of the RCT and is not included in the PEDro score.

Eligibility criteriaT

Author

APPENDIX B. QUALITY ASSESSMENT (PEDRO RATING SCALE)

Y N N Y Y Y Y Y Y Y

Y Y Y Y Y Y Y Y Y Y

Point estimate + variability

Oswestry, Roland-Morris

Daytime pain (100-mm VAS), nocturnal pain (100-mm VAS), No. of patients pain free, spinal tenderness (4-point scale), Lx flexion work status Pain VAS Gillet (SIJ ROM) score, Gait symmetry, Oswestry

ROM, SLR, pain 10-cm VAS, pain drawing, 6-point patient satisfaction scale, Roland-Morris Oswestry

Outcome measurements

B/n group comparison

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321

NSLBP

NSLBP

LBP and/or dorsal pain, plus asymmetrical restricted ROM

NSLBP

LBP +/ nonradicular leg pain

NSLBP

Hsieh et al86

Licciardone et al87

MacDonald and Bell88

Pope et al89

Triano et al90

Waagen et al91

Age N17 y; palpatory tenderness over facet joints; duration, N7 wk, or N5 episodes within preceding 52 wk Age, 18-65 y; ambulatory LBP patients; duration, N3 wk

Age, 18-55 y; good general health (self-report); duration, 3-26 wk

Age, 16-70 y; duration: 3 inception cohorts, 0-13 d, 14-28 d, N28 d

Age, 21-69 y; duration N3 mo

Age N18 y; duration, 3-26 wk, or at least 8 wk pain free in preceding 28 wk

Inclusion criteria Specific back pain because of known pathology, lower limb neurological abnormalities, pregnancy, significant mental disorders, obesity, litigation, automobile injuries, work injuries, inappropriate illness behavior, anticoagulant therapy, lumbar surgery, previous manual therapy in current episode Nerve compression, pregnancy, specific back pain because of known pathology, workers compensation or litigation, lumbar surgery, previous manual therapy for current episode, previous attendance at trial site Nerve compression pregnancy, specific back pain because of known pathology, osteomalacia or osteoporosis, spondylolisthesis, transient patients, patients seeking other physical treatment of their condition Nerve compression, fracture, tumor, infections, spondyloarthropathy, pregnancy, not overweight (Davenport index), previous manipulative therapy for this episode, previous back surgery, heart pacemaker, workers compensation or disability insurance issues Nerve compression, systemic disease potentially affecting musculoskeletal system, specific back pain because of known pathology, severe osteoporosis, patients receiving other treatment of LBP, workers compensation or pending litigation Nerve compression, pregnancy, malingering, workers’ compensation, obesity, specific back pain because of known pathology, previous manipulative therapy

Exclusion criteria

Manipulation (n = 9)

Manipulation (n = 48)

Manipulation (n = 70)

Manipulation, mobilization, massage, posture, and activity advice (n = 49)

Yes—at clinician discretion (2-6 treatments over 2 wk)

No—rotation manipulation only, but levels to be treated chosen by clinician (12 treatments over 2 wk)

Yes—at clinician discretion (treated twice weekly until self-rated recovery achieved or until 3 consecutive treatments without measurable recovery) No—rotation manipulation only, but levels to be treated chosen by clinician (9 treatments over 3 wk)

Yes—at clinician discretion (7 treatments over 5 mo)

Yes—at clinician discretion (3 treatments over 3 wk)

Lumbosacral manipulation (n = 49)

Manipulative and soft-tissue techniques (high and low force) (n = 48)

Treatment choice (treatment frequency)

Intervention procedure (sample n)

Low-force sham adjustment (sacral PA pressure) and soft tissue massage (n = 8)

(1) High-velocity low force (mimic) (n = 42), (2) back education program (n = 43)

(1) Massage (n = 37), (2) TMS (n = 28), (3) corset (n = 29)

Posture and activity advice (n = 46)

(1) Sham manual therapy, light touch, ROM activities (n = 23), (2) no treatment (n = 20)

(1) Myofascial therapy (n = 51) (3 wk for 3 wk), (2) back school (n = 48) (1 wk for 3 wk)

Control procedure and (sample n)

Pain VAS, Oswestry, ZUNG Scores, (only the back school comparison was used because the current authors could not be sure that the high-velocity low force mimic had no treatment effect) Pain VAS, Lumbar ROM, SLR, Average combined objective test results

Pain VAS, lumbar flexion, lumbar extension, mean voluntary, extension effort (%Change), Sorensen time (s), Sorensen slope

Disability index scores

Pain (10 cm) VAS, SF-36 physical function, global satisfaction

Pain (10 cm) VAS Roland-Morris

Outcome measurements

Kent et al Clinician Treatment Choice and Outcomes of Manual Therapy

TMS, Transcutaneous muscular stimulation; NSAID, nonsteroidal anti-inflammatory drug; TENS, transcutaneous electrical nerve stimulation; SIJ, sacroiliac joint; PA, posteroanterior.

Condition

RCT

322 Journal of Manipulative and Physiological Therapeutics June 2005