Abstract
BackgroundOsteopathic manipulative treatment (OMT) and ultrasound physical therapy (UPT) are commonly used for chronic low back pain. Although there is evidence from a systematic review and meta-analysis that OMT generally reduces low back pain, there are no large clinical trials that specifically assess OMT efficacy in chronic low back pain. Similarly, there is a lack of evidence involving UPT for chronic low back pain.MethodsThe OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial is a Phase III randomized controlled trial that seeks to study 488 subjects between August 2006 and June 2010. It uses a 2 × 2 factorial design to independently assess the efficacy of OMT and UPT for chronic low back pain. The primary outcome is a visual analogue scale score for pain. Secondary outcomes include back-specific functioning, generic health, work disability, and satisfaction with back care.ConclusionThis randomized controlled trial will potentially be the largest involving OMT. It will provide long awaited data on the efficacy of OMT and UPT for chronic low back pain.Trial registration, NCT00315120
Highlights
Osteopathic manipulative treatment (OMT) and ultrasound physical therapy (UPT) are commonly used for chronic low back pain
More contemporary national surveys have shown that a majority of patients who visit osteopathic physicians continue to report receiving treatment for musculoskeletal disorders [2], including osteopathic manipulative treatment (OMT) [3]
Osteopathic physicians play a unique role in treating patients with low back pain in the United States because they may provide OMT in addition to or instead of conventional medical treatment [4]
Summary
In order to provide each subject with a comparable OMT intervention across providers, subjects will be evaluated at each encounter using the "dirty half dozen" framework [31] This approach accepts that six entities are often encountered in patients with chronic low back pain: (1) non-neutral lumbar somatic dysfunction; (2) dysfunction of the symphysis pubis (pubic shear); (3) restriction of the anterior movement of the sacral base; (4) innominate shear dysfunction; (5) a short leg and pelvic tilt syndrome; Table 1: Clinical trial protocol and timetable Task*. Because sham OMT in the preliminary trial provided some therapeutic effect [12], the baseline osteopathic examination, assessment, and treatment plan will be used to guide the selection of anatomical regions for sham OMT, with the intent of avoiding those areas of somatic dysfunction that contribute most to the subject's low back pain. The study was registered as a Phase III trial with ClinicalTrials.gov in April 2006 (ClinicalTrials.gov identifier, NCT00315120)
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