PI: Arthur Weinstein, Co-PI: John Pan; Presenter: John Pan
Center for Integrative Medicine, George Washington University Medical Center, Washington, DC

This research tests the feasibility of studying traditional Chinese acupuncture in the context of a large, randomized, controlled clinical trial (RCT). The condition to be studied is carpal tunnel syndrome (CTS).

SPECIFIC AIMS:

• To determine that a "single blind-mute" methodology can be developed which will enable true and sham acupuncture to be administered in a standardized and unbiased fashion
• To identify and standardize the most appropriate invasive control (sham) acupuncture points for CTS
• To develop a Manual of Acupuncture Methods which codifies the techniques of administration of true and sham acupuncture that can be used at any site performing an RCT for CTS
• To demonstrate that patient recruitment for and retention in a small, short-term RCT of acupuncture for CTS is sufficient to justify a full-scale RCT
• To demonstrate, in an 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 pre-trial 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 needling 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 3 x 3 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, twice or three times weekly for 6 weeks. The patients will be blinded to treatment group and the acupuncturist will be mute. The primary outcome measure will be a validated CTS symptom severity scale measured at 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.

NIH Funded Acupuncture Research in Stroke and Spinal Cord Injury

Samuel C Shiflett, Center for Health and Healing, Beth Israel Medical Center, New York, NY

Three small pilot research projects studying acupuncture have been conducted at Kessler Institute for Rehabilitation (and its affiliated research organization, Kessler Medical Rehabilitation Research and Education Corporation). These have been part of broader research program funded by grant #U24-HD32994, from the NIH, to study complementary and alternative therapies in the treatment of neurological disorders, including stroke, and spinal cord injury. Two studies involved treatment of pain in spinal cord injured subjects, the other involved the treatment of dysphagia in stroke patients. Data collection in all studies has been completed, and are in various stages of preparation for publication.

Acupuncture for dysphagia in stroke (Noel Nowicki, MD, and Allison Averell, MD, principal investigators). 18 stroke inpatients diagnosed with swallowing disorder using VFSS (Video fluoroscopic swallowing study) were treated with acupuncture and contrasted to 22 control patients who received only standard of care. Using a specially constructed aspiration rating scale, it was found that the acupuncture treated group was somewhat improved compared to the control group. An interaction suggested that the treatment was more effective for men than for women, who appeared to have a better natural recovery rate.

Acupuncture and Trager for wheelchair induced shoulder pain in spinal cord patients. (Trevor Dyson-Hudson, MD, principal investigator). 18 spinal cord injured individuals with shoulder pain attributable to wheelchair overuse were randomized to either an acupuncture or a Trager bodywork condition. Both interventions showed substantial and roughly equal improvement in pain following a course of treatment. There was marginal evidence that suggested that acupuncture resulted in quicker resolution of pain than Trager, but that after three months the benefit of acupuncture was beginning to disappear (level of pain was increasing) while in the Trager group, pain remained at a lower level.

Acupuncture for pain and depression in spinal cord injured patients (Sangeetha Nayak, Ph.D., principal investigator) (co-funded by grant # 287 from the American Association of Spinal Cord Injury Psychologists and Social Workers). Twenty-two people with SCI who experienced moderate to severe pain of at least 6 months duration. The intervention consisted of a course of 15 acupuncture treatments administered over a 7½-week period. Forty-six percent of the sample showed improvement in pain intensity and pain sequelae following treatment. Treatment success may be related to whether the injury is complete and whether pain is above or below the level of injury. Risk of autonomic dysreflexia was monitored and found to be negligible.