Acupuncture for relieving symptoms of Gulf War Illness
Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness
NA · University of Utah · NCT06716411
This trial will test whether regular acupuncture can help veterans with Gulf War Illness feel less fatigued, have less pain, and improve physical functioning.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah (other) |
| Locations | 10 sites (Berkeley, California and 9 other locations) |
| Trial ID | NCT06716411 on ClinicalTrials.gov |
What this trial studies
This randomized, unblinded Phase II trial compares individualized acupuncture delivered in community practice settings by experienced practitioners to a waitlist-then-treatment schedule for veterans with Gulf War Illness. Two hundred veterans are randomized to either six months of twice-weekly acupuncture or a two-month waitlist followed by weekly acupuncture, with practitioners required to have at least five years’ experience plus study training. Outcomes, including the SF-36 physical component score, are measured at baseline and at 2, 4, and 6 months. The protocol uses acupuncture approaches typical of community practice to test real-world effects on multisymptom illness burden.
Who should consider this trial
Good fit: Ideal candidates are veterans deployed to the Gulf Theater since 1990 who meet CDC-based Gulf War Illness criteria (at least two of three symptom clusters with at least one severe symptom) and can attend in-person acupuncture sessions.
Not a fit: Patients who do not meet the CDC symptom cluster criteria, who are currently enrolled in other clinical trials, or who have conditions that make acupuncture unsafe may be unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, acupuncture could reduce physical symptoms and improve quality of life for veterans with Gulf War Illness.
How similar studies have performed: Some small studies of acupuncture for chronic pain and related multisymptom conditions have shown symptom improvements, but rigorous evidence specifically for Gulf War Illness is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Have at least 2 of the following symptoms from the 3 CDC clusters of symptom that have lasted for more than 6 months. Each symptom cluster must be characterized as mild-moderate or severe, with at least one symptom in each cluster required to be severe. The clusters are: A. Fatigability: fatigue 24 hours or more after exertion B. Mood and Cognition: feeling depressed; feeling irritable; difficulty thinking or concentrating; feeling worried, tense, anxious; problems finding words; or problems getting to sleep C. Musculoskeletal: joint pain or muscle pain Exclusion Criteria: * 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.
Where this trial is running
Berkeley, California and 9 other locations
- University of California, Berkeley — Berkeley, California, United States (NOT_YET_RECRUITING)
- Various — Los Angeles, California, United States (RECRUITING)
- Various — Colorado Springs, Colorado, United States (NOT_YET_RECRUITING)
- Various — Denver, Colorado, United States (NOT_YET_RECRUITING)
- Various — Tampa, Florida, United States (RECRUITING)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Various — Dallas, Texas, United States (RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
- Various — Fairfax, Virginia, United States (NOT_YET_RECRUITING)
- Various — Seattle, Washington, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Lisa Conboy
- Email: lisa_conboy@hms.harvard.edu
- Phone: 617-718-1917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persian Gulf Syndrome, Gulf War Syndrome, Multiple Chronic Illnesses, Occupational Diseases, War-Related Injuries, Wounds and Injuries, Acupuncture, Gulf War Illness