Evidence Base for OMT in Patients With Low Back Pain

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Eustace Bridges
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3 Evidence Base for OMT in Patients With Low Back Pain Kevin D. Treffer, D.O. Associate Professor of Family Medicine Department of Family Medicine KCUMB-COM

4 Lecture Objectives Be able to describe the process for developing national Clearinghouse guidelines Understand the background for the development of these guidelines Be able to discuss the evidence that the guidelines is based upon Implement the algorithm from the guidelines into daily practice Understand the how this effects daily practice of Osteopathic Medicine

5 The Charge Develop a clinical guideline that is published is based on solid research evidence for the use of OMT in Low Back Pain

6 The Process AOA Bureau of Osteopathic Clinical Education and Research The Clinical Guideline Subcommittee on Low Back Pain

7 The Process OMT is a distinctive modality used by DO s to complement conventional treatment for musculoskeletal disorders that cause low back pain Using manually guiding forces to improve physiologic function and support homeostasis, altered by somatic dysfunction Unique philosophical approach Hands of treatment + conventional therapies

8 The Process Osteopathic Survey of Health Care in America Majority of patients visiting DO s for treatment of MS conditions OMT a distinctive element of the care of low back pain Agency for Health Care Policy and Research in the US Comprehensive evaluation of spinal manipulation Concluded manipulation helpful for low back pain without radiculopathy within first month of symptoms Most of these studies involved chiropractic and PT Unclear if this could reflect efficacy of OMT for low back pain Thus the need for empirical data that OMT is efficacious

9 The Process The goal of the undertaking was to enable DO s, other Health professionals, and Third Party Payers to understand the evidence on the appropriate utilization of OMT No current guidelines detail this to date

10 The Process The patient population this is intended for Low back pain patients of MS origin Low back pain referred from visceral origin are excluded from these guidelines Other exclusions Vertebral fracture/dislocation, muscle tears/lacerations, spinal ligament rupture, discitis, sacroiliitis, ankylosing spondylitis, masses, inflammation of facets/muscles/fascia This does not imply that OMT is contraindicated in these conditions

11 The Process Searched English language literature through 2006 MEDLINE, OLDMEDLINE, EMBASE, MANTIS, OSTMED, Alt Health Watch, SciSearch, ClinicalTrials.gov, CRISP, Cochrane Central Register of Controlled Trials Reviews/meta-analyses of spinal manipulation, search of citations in reviewed literature, manual searches of key osteopathic journals Eligibility Randomized controlled trials of OMT Blinded assessment of low back pain in ambulatory setting Trials with manipulation under anesthesia, industrial settings, or hospitalized patients all excluded

12 The Process 7 trials met criteria for inclusion Each trail was independently evaluated by 2 reviewers to abstract data Methodological characteristics OMT & control treatments Low back pain outcomes

13 Evaluation of the Data Statistical Analysis Effect size (greater the negative number the greater the decrease in pain among OMT subjects) Cohen s d statistic P-value two-tailed t-test meta-analysis Q-statistic (for homogeneity of trials)

14 Evaluation of the Data Results 525 subject with low back pain randomized in the eligible trials Highly significant reduction in pain associated with OMT Effect size -0.30, 95% CI , P=.001 Q statistic not significant Supports assumption of homogeneity of trials included in study

15 Evaluation of the Data Results continued, Random-effect model results virtually identical to fixed-effect models Subgroup Analysis Low back pain with OMT vs active Treatment or placebo control Effect size -0.26, 95% CI , P=.02 OMT vs no treatment control comparisons OMT and usual care vs only usual care Effect size -0.29, 95% CI , P=0.50

16 Evaluation of the Data Subgroup analysis on follow up Short term (< 3 months) Effect size -0.28, 95% CI , P=.01 Intermediate term ( 3-9 months) Effect size -0.33, 95% CI , P<.001 Long term ( up to 1 yr.) Effect size -0.40, 95% CI , P=.03

17 Discussion Has been suggested that a therapeutic benefit from spinal manipulation largely due to placebo effects Sensitivity analysis of the trials supports efficacy of OMT vs active treatment/placebo pain reduction due to OMT not placebo effect

Discussion Compared to effects of NSAIDS (Cox-2 inhibitors) Meta analysis of 23 randomized placebo controlled trials 10,000 subject (followup up

18 Discussion Compared to effects of NSAIDS (Cox-2 inhibitors) Meta analysis of 23 randomized placebo controlled trials 10,000 subject (followup up to 3 months) Effect size % CI Effect size % CI when drug non-responders were not excluded from analysis

19 Discussion Compared to effects of NSAIDS (Cox-2 inhibitors) continued Thus the Osteopathic meta-analysis Effect size % CI OMT vs active treatment or placebo control Suggests that the OMT provides analgesic effect comparable to NSAIDS Unlike the NSAID meta-analysis the DO analysis showed pain reduction in the 3-12 month period Decrease costs and potential side effects of medications For MS back pain: DO s admit to hospital less, refer less for treatment, less radiographs, less drugs, and less patient visits (compared to Chiropractors)

20 Discussion Based on this meta-analysis of RCT on OMT for patients with low back pain The evidence is considered 1a OMT is recommended to be utilized by osteopathic physicians for musculoskeletal causes of low back pain

21 Levels of Evidence 1a 1b 1c 2a 2b Strength of evidence Systematic review with homogeneity of randomized controlled trials Individual randomized controlled trial with narrow confidence interval Differential frequency of adverse outcomes Systematic review with homogeneity of cohort studies Individual cohort study or lowquality randomized controlled trial Type of Study Comment Individual trials should be free of substantial variations in the directions and magnitudes of results Confidence interval should indicate a clinically important OMT effect An adverse outcome was frequently observed in patients who did not receive OMT, but was infrequently observed in patients who did receive OMT (equivalent to a small number needed to treat) Individual studies should be free of substantial variations in the directions and magnitudes of OMT effects Low quality may be indicated by such factors as important differences in baseline characteristics between groups, lack of concealment of treatment allocation, and excessive losses to follow-up

22 3a Systematic review with homogeneity of case-control studies Individual studies should be free of substantial variations in the directions and magnitudes of OMT effects 3b Individual case-control study These should be free of substantial evidence of selection bias, information bias, or confounding variables 4 Case series and low quality cohort and case-control studies 5 Expert opinion without explicit critical appraisal, or based on physiology, bench research, or "first principles" Low quality of cohort and case control studies may be indicated by such factors as important sources of selection bias, information bias, or confounding variables These generally will have limited empirical data relevant to OMT effects in human populations *Adapted from Straus SE, Richardson WS, Glasziou P, and Haynes RB, Evidence-Based Medicine. How to Practice and Teach EBM (3rd ed), 2005

23 Discussion OMT for somatic dysfunction has not demonstrated harm in any clinical trials to date.

24 Is Somatic dysfunction the cause, or a contributing factor, in the presentation of LBP (Look for Red Flags. ) No Identify cause of LBP and treat accordingly. Yes Cause: A) Define type of dysfunctional mechanics and as appropriate, define the dysfunctional barrier. Contributing factor: Identify primary cause of LBP and treat accordingly. Treat contributing somatic dysfunction using the same decision making as followed if the LBP is solely the result of somatic dysfunction. B) Determine why the dysfunction is present (e.g., articular, muscular, myofascial, neuroreflex, membranous). C. Determine the patient s level of tolerance for OMT.

25 D) Decide upon the type of OMT to most effectively address the cause of the dysfunction with consideration for patient tolerance. E) Apply OMT to accomplish the desired response. F) Reassess the dysfunction and determine if and when followup evaluation is necessary. Follow-up, if appropriate, and repeat steps A-F.

26 Discussion Barriers to the application of the recommendations Poor reimbursement for OMT Medicare has reimbursed DO s for OMT >30 years ICD-9 code with a 25 modifier attached to the E&M code Time constraints Lack of confidence or loss in skills Inadequate office space Some specialties (ie. Radiology or pathology)

27 Conclusion WE HAVE A NATIONAL CLINCAL PRACTICE GUIDELINE FOR OMT FOR PATIENTS WITH LOW BACK PAIN REGISTERED AND PUBLISHED ON THE NATIONAL GUIDELINES CLEARINGHOUSE WEBSITE AND THE AOA S WEBSITE.

28 Conclusion This was voted and approved by the AOA HOD followed by the AOA Board of Trustees. Given the high level of evidence the AOA recommends/supports the use of OMT in low back pain patients Changes in the care of these patients from the implementation of the guidelines measured by Physician and patient surveys, billing and coding practices, data from AOA s Clinical Assessment Program, and other registry data developed by researchers.

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