Clinical Trial: Acupuncture in the Treatment of Gulf War Illness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acupuncture in the Treatment of Gulf War Illness

Brief Summary: This unblinded Phase II clinical trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

Detailed Summary:

Gulf War Illness (GWI) is a complex, poorly understood illness characterized by many symptoms, including fatigue after exertion, sleep and mood problems, difficulty concentrating, difficulty thinking and finding words, and musculoskeletal pain. Individuals often present with many symptoms, some of them severe and disabling, and with additional medical diagnoses, including chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome, digestive complaints, and mood-related psychiatric disorders, such as depression, posttraumatic stress disorder, and other anxiety disorders. More than 100,000 veterans of the first Gulf War (Operation Desert Shield/Storm, 1990-1991) out of 700,000 US service personnel deployed to the Persian Gulf have presented with medical complaints through programs established to address the problem, which came to be called chronic multisymptom illness (CMI). Groups of veterans in the United Kingdom, Canada, and Australia have been identified with similar problems. The veterans have received treatment directed at their symptoms, but at 5- and 10-year follow-ups, many reported their symptoms remained, some of them severe and disabling. Clearly, an effective treatment for these conditions would be of great benefit to those who were injured during their military service.

The cause of CMI is unknown, and the symptoms can not be explained by physical and laboratory examinations. Several factors have been considered, including exposure to vaccines, chemicals likely to be encountered in combat (chemical weapons, smoke, pesticides) and stress related to military service, deployment, and combat. After investigation by the Centers for Disease Control (CDC), researchers suspect that the symptoms reflect a range of injuries to the nervous system. It may be that the factors that led to these injuries were not specific to the Persian Gulf region, and that veterans o
Sponsor: New England School of Acupuncture

Current Primary Outcome: SF-36P [ Time Frame: 6 months ]

Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.


Original Primary Outcome: Statistically significant changes in Sf-36 scores at 2 months of treatment. [ Time Frame: 2 months ]

A short-form health survey with 36 questions


Current Secondary Outcome:

Original Secondary Outcome:

Information By: New England School of Acupuncture

Dates:
Date Received: February 24, 2011
Date Started: July 2009
Date Completion:
Last Updated: May 20, 2015
Last Verified: May 2015