Recruiting

Acupuncture

Sponsor:

University of Utah

Code:

NCT06716411

Conditions

Persian Gulf Syndrome

Gulf War Syndrome

Multiple Chronic Illnesses

Occupational Diseases

War-Related Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Study Details

Brief 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).

Conditions

Persian Gulf Syndrome

Gulf War Syndrome

Multiple Chronic Illnesses

Occupational Diseases

War-Related Injuries

Study ID

NCT06716411

Start date

Feb 3, 2026

Status verified date

Apr, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bi-weekly acupuncture treatment

Bi-weekly acupuncture treatment

active comparator: Wait list

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

Interventions

Acupuncture

Sterile insertive needles are applied by licensed, experienced practitioners.

Primary outcome measure

  • SF-36P [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lisa Conboy

617-718-1917lisa_conboy@hms.harvard.edu

Locations

Various

Recruiting

Los Angeles, California, United States, 90015

Contacts

CARE Study Research Team

801-646-8308gwi@utah.edu

Various

Recruiting

Tampa, Florida, United States, 33762

Contacts

CARE Study Research Team

801-646-8308GWI@utah.edu

Various

Recruiting

Dallas, Texas, United States, 75231

Contacts

CARE Study Research Team

801-646-8308GWI@utah.edu

More Information

Sponsor

University of Utah

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

  • Acupuncture
  • Gulf War Illness
  • Complex Medical Illness
  • Chronic Multisymptom Illness
  • Veteran

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-04-03.