RecruitingNot ApplicableNCT06716411

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


Sponsor

University of Utah

Enrollment

200 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DEVICEAcupuncture

Sterile insertive needles are applied by licensed, experienced practitioners.


Locations(10)

University of California, Berkeley

Berkeley, California, United States

Various

Los Angeles, California, United States

Various

Colorado Springs, Colorado, United States

Various

Denver, Colorado, United States

Various

Tampa, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Various

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Various

Fairfax, Virginia, United States

Various

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06716411


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