Acupuncture for Gulf War Syndrome
(CARE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of 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

This trial is for veterans with Gulf War Illness, a condition affecting those who served in the Persian Gulf War. It includes chronic symptoms like fatigue and pain. Participants should have these symptoms but not other conditions like Klinefelter or Triple X Syndrome.

Inclusion Criteria

I have had severe symptoms in at least 2 of the CDC's symptom clusters for over 6 months.

I served in the Gulf region from August 1990 to now.

Exclusion Criteria

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)

Currently enrolled in another clinical trial

Unable to complete the protocol based on the evaluation of the Medical Monitor.

+1 more

Participant Groups

The study tests acupuncture's effectiveness on Gulf War Illness symptoms. Two groups of participants will receive treatments from experienced acupuncturists: one gets biweekly sessions for six months, the other starts with a two-month wait then weekly sessions.

2Treatment groups

Experimental Treatment

Active Control

Group I: Bi-weekly acupuncture treatmentExperimental Treatment1 Intervention

Bi-weekly acupuncture treatment

Group II: Wait listActive Control1 Intervention

Wait list for 2 months followed by weekly acupuncture for 4 months

Acupuncture is already approved in United States, European Union, China, Australia for the following indications:

🇺🇸 Approved in United States as Acupuncture for: