Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain

A Randomized Controlled Trial

John C. Licciardone, DO, MS, MBA; Dennis E. Minotti, DO; Robert J. Gatchel, PhD; Cathleen M. Kearns, BA; Karan P. Singh, PhD

Disclosures

Ann Fam Med. 2013;11(2):122-129. 

In This Article

Discussion

This study shows that OMT is efficacious for short-term pain relief when used to complement other co-treatments for chronic low back pain. Responder analysis confirmed that OMT met or exceeded the Cochrane Back Review Group criterion for a medium effect size for both moderate and substantial improvements in low back pain. Thus, low back pain reductions with OMT were statistically significant and clinically relevant. The less frequent use of prescription drugs for low back pain reported by OMT patients further corroborates the clinical relevance of our low back pain outcomes. Notably, these drugs were prescribed by independent nonstudy physicians who were blinded or unaware that their patients were participating in our study. Moderate to substantial pain reductions, such as those observed with OMT, have been associated with decreased need for rescue medication.[26] Another trial reported decreased medication use with OMT, but without corresponding efficacy in relieving low back pain.[11] Our results may begin to explain why one-third of ambulatory, chronic problem visits for low back pain in the United States are provided by osteopathic physicians, and why they less frequently prescribe medications, such as nonsteroidal anti-inflammatory drugs, than allopathic physicians during such visits.[1]

There are concerns that chronic low back pain is often managed with costly and invasive treatments of questionable efficacy and safety.[36] Our results support the efficacy and safety of OMT; however, they do not address its cost-effectiveness. Nevertheless, the OMT regimen of 6 treatments was within the guidelines developed in the United Kingdom by the National Institute for Health and Clinical Excellence, which recommend up to 9 spinal manipulation treatment sessions over 12 weeks.[5] Our results may be generalizable to other manual therapies because several OMT techniques in our protocol have been accepted for low back pain treatment by professional associations representing chiropractors and physiotherapists.[37] Biweekly maintenance treatments with spinal manipulation extend short-term low back pain reductions for 9 months.[20] A systematic review suggests that low back pain reductions with OMT may extend up to 1 year.[30] Thus, a larger trial is warranted to assess the efficacy and cost-effectiveness of OMT at long-term endpoints.

To our knowledge, this OMT trial is the largest ever conducted. Other strengths of our study include allocation concealment, similarity of baseline patient characteristics across treatment groups, blinding of outcome assessors, high levels of treatment adherence and outcomes reporting, and intention-to-treat analysis. Our analysis and interpretation of the primary outcomes was consistent with IMMPACT recommendations.[24,38] We also collected data on concurrent low back pain co-treatments to pragmatically assess the effectiveness of OMT as it is provided in real-life settings (ie, as a complement, rather than an alternative, to self-care and usual care for low back pain).

There were limitations of our study. Comorbid conditions, work disability, and low back pain co-treatments were self-reported by patients, but were not verified through medical or employment records. Also, missing data had to be imputed for 13% of patients at the final encounter. Nevertheless, sensitivity analysis using 2 alternate approaches corroborated our low back pain outcomes.

Imperfect placebo treatments are common in low back pain trials.[39] The factorial design limited our ability to assess the sham OMT and sham UST treatments for their independent placebo effects. According to a Cochrane Collaboration review,[6] only 1 trial of spinal manipulation for chronic low back pain has ever evaluated patient blinding.[40] The investigators in that trial reported a mean pain score reduction of 6 mm (16% from baseline) on a visual analog scale, with 6 sham manipulation treatments over 2 weeks, and concluded that blinding was adequate.[40] Similarly, when extrapolated to a 100-mm visual analog scale with a standard deviation of 25 mm,[31] a systematic review of 27 clinical trials reported a standardized mean effect corresponding to a pain reduction of 7 mm with placebo treatments.[19] By comparison, our sham OMT patients achieved a median pain score reduction of 9 mm (20% from baseline) on a visual analog scale, with 6 treatments over 8 weeks. Nevertheless, some degree of unblinding remained possible despite these surrogate data on patient blinding.

In conclusion, the OMT patients achieved moderate to substantial improvements in low back pain, which met or exceeded the Cochrane Back Review Group criterion for a medium effect size. The OMT patients also reported less frequent concurrent use of prescription drugs. They did not, however, report corresponding improvements in back-specific functioning, general health, or work disability. The OMT regimen was safe, parsimonious, and well accepted by patients as demonstrated by high levels of treatment adherence and satisfaction with back care. By contrast, UST was not efficacious in relieving chronic low back pain.

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