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

Not Applicable

Not yet recruiting

• Conditions: Persian Gulf Syndrome; Gulf War Syndrome; Multiple Chronic Illnesses; Occupational Diseases; War-Related Injuries; Wounds and Injuries

• Registration Number: NCT06716411
• Lead Sponsor: University of Utah

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 ...

Detailed Description

Gulf War Illness (GWI), or chronic multisymptom illness (CMI), is a complex illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain, which are unexplained by physical and laboratory examinations. There is no standard of care treatment for this syndrome at this time. First def...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-08-16
• Status Verified: 2024-11
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SF-36P	6 months	Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.

Trial Locations

Locations (3)

University of California, Berkeley; 🇺🇸 Berkeley, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States