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A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain
Daniel C. Cherkin, PhD;
Karen J. Sherman, PhD;
Andrew L. Avins, MD, MPH;
Janet H. Erro, RN, MN;
Laura Ichikawa, MS;
William E. Barlow, PhD;
Kristin Delaney, MPH;
Rene Hawkes, BA;
Luisa Hamilton, MD;
Alice Pressman, MS;
Partap S. Khalsa, DC, PhD;
Richard A. Deyo, MD, MPH
Arch Intern Med. 2009;169(9):858-866.
Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain.
Methods A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks.
Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05).
Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.
Trial Registration clinicaltrials.gov Identifier: NCT00065585
Author Affiliations: Center for Health Studies, Seattle, Washington (Drs Cherkin, Sherman, and Barlow and Mss Erro, Ichikawa, Delaney, and Hawkes); Division of Research, Northern California Kaiser Permanente, Oakland (Drs Avins and Hamilton and Ms Pressman); Cancer Research and Biostatistics, Seattle (Dr Barlow); Division of Extramural Research and Training, National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, Maryland (Dr Khalsa); and Department of Family Medicine, Oregon Health and Science University, Portland (Dr Deyo).
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