Spine (Phila Pa 1976) 2003 (Jul); 28 (13): 1355–1362
Here's another study with the unusual finding that the sham and the active treatment groups both fared similarly...that is, both groups improved, compared to the control group. It would be interesting to know the exact nature of the sham they were using. The Placebo/Sham Page is devoted to this issue...the difficulty in designing a truly inert sham or placebo for a manipulative trial.
By Laurie Barclay, MD
July 8, 2003 — Osteopathic manipulation is no better than sham therapy for chronic nonspecific low back pain, according to the results of a randomized trial published in the July issue of Spine.
However, both osteopathic and sham manipulation were more effective than no therapy.
"Osteopathic manipulative treatment may be useful for acute or subacute low back pain," write John C. Licciardone, DO, from the University of North Texas Health Science Center in Fort Worth, and colleagues. "However, its role in chronic low back pain is unclear."
Of 199 subjects recruited at a university-based clinic from 2000 through 2001, 91 met eligibility criteria and were randomized to osteopathic manipulative treatment, sham manipulation, or a no-intervention control group. At baseline, there were no significant differences between groups. All subjects were allowed to continue their usual care for low back pain. Of 82 patients who completed the one-month follow-up evaluation, 71 completed the three-month evaluation, and 66 completed the six-month evaluation.
Outcome measures included the SF-36 Health Survey, a 10-cm visual analog scale for overall back pain, the Roland-Morris Disability Questionnaire, lost work or school days because of back pain, and satisfaction with back care.
Compared with the no-intervention control group, the osteopathic manipulation group reported greater improvements in back pain, greater satisfaction with back care, better physical functioning and mental health at one month, and fewer cotreatments at six months. However, the sham manipulation group also reported greater improvements in back pain and physical functioning and greater satisfaction than the control group, and osteopathic manipulation was not significantly better than sham manipulation.
Study limitations include use of medical students to perform manipulation, use of more usual-care interventions in the no-intervention control group, relatively low disability levels, lack of statistical power to detect small differences between groups, and loss of 27% of subjects to follow-up. The authors therefore recommend additional research.
"Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain," the authors write. "It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects."
The American Osteopathic Association partially supported this study.