Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06716411

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

Led by University of Utah · Updated on 2026-04-03

200

Participants Needed

10

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of personalized acupuncture treatments on veterans diagnosed with Gulf War Illness (GWI), a complex condition marked by symptoms like fatigue, sleep and mood problems, cognitive issues, and muscle pain. This trial builds on prior research showing acupuncture may improve pain and function in this population. It is a Phase II, unblinded study that compares two different acupuncture treatment schedules to better understand their impact on the physical health of veterans with GWI. Participants will be randomly assigned to one of two groups: one group will receive acupuncture twice a week for six months, and the other will wait for two months before receiving weekly acupuncture for four months. Treatments involve sterile needles applied by licensed practitioners with at least five years of experience plus additional study training. Measurements will be taken at the start, 2, 4, and 6 months, focusing on physical health improvements. During the study, veterans will complete assessments including questionnaires and medical evaluations to measure symptom severity and physical function. Blood samples will be collected to explore biological markers related to GWI and treatment effects. The main outcome is the change in physical health after six months, measured by the SF-36 physical component scale. The study will monitor progress and safety throughout the treatment period, lasting up to six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Deployed to the Gulf Theater of operations (including 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 airspace above) between August 1990 and the present
  • Have at least two symptoms from the CDC symptom clusters lasting more than 6 months, with at least one symptom in each cluster being severe: fatigability (fatigue after exertion), mood and cognition (depression, anxiety, difficulty concentrating, sleep problems), and musculoskeletal pain (joint or muscle pain)
Not Eligible

You will not qualify if you...

  • Currently enrolled in another clinical trial
  • Have another disease likely explaining symptoms as determined by the Medical Monitor
  • Severe psychiatric illness in the last 2 years (psychiatric hospitalization, suicide attempt, substance abuse, or use of antipsychotic medication)
  • Unable to complete the study protocol based on Medical Monitor evaluation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive acupuncture treatments to relieve symptoms of Gulf War Illness. One group receives acupuncture twice per week for 6 months. Another group is on a wait list for 2 months, then receives weekly acupuncture for 4 months.

Twice-weekly visits for 6 months or weekly visits for 4 months after 2 months wait list

Trial Site Locations

Total: 10 locations

1

University of California, Berkeley

Berkeley, California, United States, 94720

Not Yet Recruiting

2

Various

Los Angeles, California, United States, 90015

Actively Recruiting

3

Various

Colorado Springs, Colorado, United States, 80911

Not Yet Recruiting

4

Various

Denver, Colorado, United States, 80203

Not Yet Recruiting

5

Various

Tampa, Florida, United States, 33762

Actively Recruiting

6

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

7

Various

Dallas, Texas, United States, 75231

Actively Recruiting

8

University of Utah

Salt Lake City, Utah, United States, 84111

Not Yet Recruiting

9

Various

Fairfax, Virginia, United States, 23235

Not Yet Recruiting

10

Various

Seattle, Washington, United States, 98116

Not Yet Recruiting

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Research Team

L

Lisa Conboy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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