About this trial
This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).
Eligibility criteria
Qualifiers
Deployed to the Gulf Theater of operations (as defined by 38 CFR 3.317, includes Iraq, Kuwait, Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above all of these locations) between August 1990 and the present date
Disqualifiers
Currently enrolled in another clinical trial
Have another disease that likely could account for the symptoms, as determined by our Medical Monitor
Severe psychiatric illness (in the last 2 years psychiatric hospitalization, suicidal attempt, alcohol or substance abuse, use of antipsychotic medication) as measured by the Primary Care Evaluation of Mental Disorder (Prime MD).
Unable to complete the protocol on based on the evaluation of the Medical Monitor.
Trial design
Treatments tested in this trial
- Acupuncture
Treatment groups
Sponsors and collaborators
University of Utah
Lead sponsor
United States Department of Defense
Collaborator
University of California, Berkeley
Collaborator
Beth Israel Deaconess Medical Center
Collaborator