Are there any orthopaedic CAM trials?

NCCAM has made awards to study a number of health conditions and populations. Included are a large number of Phase I (to evaluate safety), Phase II (to access clinical activity) and Phase III clinical trials (to determine clinical efficacy) of a range of CAM therapies.

Efficacy of Acupuncture in the Treatment of Fibromyalgia (Dedra A. Buchwald, MD, University of Washington) - 96 patients with fibromyalgia will be recruited for a 12-week, 24-treatment, 3-arm, randomized, controlled Phase II clinical trial. The active treatment group will receive true acupuncture. Control groups will be treated with acupuncture for an unrelated condition. These patients will receive needle insertion at non-channel, non-point locations, or a true placebo. Short and long-term efficacy and side effects will be measured using both subjective and objective measures of overall health and pain, to determine the optimal duration of treatment and examine the concordance of allopathic and acupuncture-based measures of outcome.

Evaluating the Efficacy of Acupuncture for Back Pain (Daniel Cherkin, DrPH, Center for Health Studies, Seattle, Washington) Cofounded with the Agency for Healthcare Research and Quality - The goals of this Phase II study are 1) to develop and evaluate methods for improving randomized trials to assess the efficacy of acupuncture, and 2) to use this information to design and pilot-test a randomized clinical trial of acupuncture for persistent low back pain. The trial will compare acupuncture to standard medical care, and standardized to individualized acupuncture treatment.

Pilot Study of Acupuncture in Fibromyalgia (Daniel J. Clauw, MD, Georgetown University Medical Center) - A randomized, blinded, sham-controlled, 2-by-2 factorial Phase II trial will be conducted to examine the individual and synergistic effects of needle placement and stimulation on the efficacy of acupuncture as a therapeutic modality in fibromyalgia. The design allows determination of dose-effect for the analgesic effect of acupuncture.

Trial of Acupuncture for Carpal Tunnel Syndrome (Arthur Weinstein, MD, George Washington University Medical Center) - The major specific aim of this pilot study is to demonstrate that using a "single blind-mute" methodology, true and sham acupuncture can be administered in a standardized and unbiased fashion. The condition to be studied is carpal tunnel syndrome (CTS), a common, well-delineated syndrome causing hand pain with characteristic clinical and objective electrodiagnostic findings. Other aims of this study are: 1) to identify and standardize the most appropriate sham acupuncture points for CTS, 2) to develop a manual that standardizes the administration of true and sham acupuncture that can be used at any study site performing a randomized clinical trial (RCT) 3) to demonstrate that patient recruitment for and retention in an RCT of acupuncture for CTS is sufficient to justify a full-scale RCT, 4) to determine, in a small Phase II RCT, whether true acupuncture provides meaningful benefit for pain in CTS compared to sham acupuncture and whether the frequency of administration of acupuncture influences the outcome.

Usual Care vs. Choice of Alternative Therapy for Low Back Pain (David M. Eisenberg, MD, Beth Israel Deaconess Medical Center) - Patients with uncomplicated acute low back pain will be randomized in this Phase III trial to either usual care or choice of expanded benefits (chiropractic, acupuncture, or massage therapy). It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, and a decrease in utilization of conventional medical services, and will be more satisfied with their care.

RCT - Acupuncture Safety/Efficacy in Knee Osteoarthritis (Brian Berman, MD, University of Maryland, Baltimore) - This multisite, Phase III trial is designed to determine the short - and long-term safety and efficacy of acupuncture in the treatment of elderly patients with osteoarthritis of the knee using three randomly assigned participated groups for comparison: (1) true acupuncture group, (2) sham acupuncture group, and (3) education and attention control group.

Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention (Brian Berman, MD, University of Maryland) - Sponsored by the National Center for Complementary and Alternative Medicine - This Phase II trial aims to determine if twelve weeks of multiple component mind-body therapy in experimental groups improves short term (at 12 weeks) and/or long term (at 24 weeks) outcomes in fibromyalgia patients as compared with twelve weeks of education and attention in control groups. A secondary aim is to determine if there are patient characteristics associated with any improvements, either short or long term.

The Effects of Black Cohosh on Menopausal Hot Flashes (Fredi Kronenberg, PhD, Columbia University Rosenthal Center for CAM) - This Phase II trial plans to study the effects of the herb black cohosh on menopause and its symptoms, including bone density and heart disease. The investigators suggest that some women may choose natural alternatives over estrogen replacement therapy for relief of menopausal symptoms.