Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

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

200 Participants
are divided into 2 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