Principal Investigator: Arthur Weinstein
Abstract: This research tests the feasibility of studying traditional Chinese acupuncture in the context of a large, randomized controlled clinical trial (RCT). 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 which standardizes the administration of true and sham acupuncture that cna be used at any study site performing an RTC, 3) to demonstrate that patient recruitment for and retention in an RCT of acupuncture for CTS us sufficient to justify a full-scale RCT, 4) to determine, in a small 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. In a pretrial session, standardization of the true and sham acupuncture techniques will be accomplished, the blind-mute methodology tested, the acupuncturists trained to deliver acupuncture (true or sham) in an unbiased manner and a Manual of Acupuncture Methods will be developed. This manual will address not only the location of true and sham acupuncture points but also the angle and depth of needing and the optimum technique to preserve credibility of the sham. The credibility of 2 separate sham acupuncture groups (each with a different set of sham points) will be tested. The subsequent RCT will be a 3X3 design involving 144 patients (9 cells at 16 patients per cell) with symptoms of CTS and evidence of median nerve conduction abnormality. Patients will be randomized to receive either true or two types of sham acupuncture at frequencies of once, two or three times weekly for 6 weeks. The patients will ber blinded to treatment group and the acupuncturist will be mute. The primary outcome measure will be validated CTS symptom severity scale measured t baseline and 2 weeks after termination of the acupuncture treatments. The study as outlined addresses the specific aims and, if successful, should enable the undertaking of a full-scale RCT employing acupuncture for CTS or other common causes of hand pain, including work-related repetitive stress injury.
Funding Period: 1999-05-14 - 2002-07-31
more information: NIH RePORT