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

NCT06716411 | Recruiting DMC FDA Device

• 1 other identifier: TX230133
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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; Wounds and Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SF-36P

  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.

  6 months

Other Outcomes (3)

• Blood Draw

  6 months

• McGill Pain Scale

  6 months

• Heart rate variability (HRV)

  6 months (starting two weeks before treatment starts until the end of treatment)

Study Arms (2)

Bi-weekly acupuncture treatment

EXPERIMENTAL

Bi-weekly acupuncture treatment

Device: Acupuncture

Wait list

ACTIVE COMPARATOR

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

Device: Acupuncture

Interventions

Acupuncture DEVICE

Sterile insertive needles are applied by licensed, experienced practitioners.

Bi-weekly acupuncture treatment; Wait list

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• University of Utah: lead
• University of California, Berkeley: collaborator

Study Sites (10)

University of California, Berkeley

Berkeley, California, 94720, United States

NOT YET RECRUITING

Various

Los Angeles, California, 90015, United States

RECRUITING

Various

Colorado Springs, Colorado, 80911, United States

NOT YET RECRUITING

Various

Denver, Colorado, 80203, United States

NOT YET RECRUITING

Various

Tampa, Florida, 33762, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Various

Dallas, Texas, 75231, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84111, United States

NOT YET RECRUITING

Various

Fairfax, Virginia, 23235, United States

NOT YET RECRUITING

Various

Seattle, Washington, 98116, United States

NOT YET RECRUITING

MeSH Terms

Conditions

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

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Lisa Conboy

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: December 4, 2024
• Study Start: February 3, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (10)