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Clinical Trial NCT06716411 (CARE) for Persian Gulf Syndrome, Gulf War Syndrome, Multiple Chronic Illnesses, Occupational Diseases, War-Related Injuries, Wounds and Injuries is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness (CARE) 200 Randomized Veterans
Clinical Trial NCT06716411 (CARE) is an interventional study for Persian Gulf Syndrome, Gulf War Syndrome, Multiple Chronic Illnesses, Occupational Diseases, War-Related Injuries, Wounds and Injuries that is recruiting. It started on 3 February 2026 with plans to enroll 200 participants. Led by University of Utah, it is expected to complete by 30 September 2028. The latest data from ClinicalTrials.gov was last updated on 11 February 2026.
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 mon...Show More
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 defined by the Centers for Disease Control and Prevention (CDC)...Show More
Official Title
Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness
Conditions
Persian Gulf SyndromeGulf War SyndromeMultiple Chronic IllnessesOccupational DiseasesWar-Related InjuriesWounds and InjuriesOther Study IDs
- CARE
- TX230133
- TX230133 (Other Grant/Funding Number) (Department of the Army)
NCT ID Number
Start Date (Actual)
2026-02-03
Last Update Posted
2026-02-11
Completion Date (Estimated)
2028-09-30
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Acupuncture
Gulf War Illness
Complex Medical Illness
Chronic Multisymptom Illness
Veteran
Gulf War Illness
Complex Medical Illness
Chronic Multisymptom Illness
Veteran
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBi-weekly acupuncture treatment Bi-weekly acupuncture treatment | Acupuncture Sterile insertive needles are applied by licensed, experienced practitioners. |
Active ComparatorWait list Wait list for 2 months followed by weekly acupuncture for 4 months | Acupuncture Sterile insertive needles are applied by licensed, experienced practitioners. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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 Responsible Party
Lisa J Taylor-Swanson, Principal Investigator, Principal Investigator, PhD, University of Utah
Study Central Contact
Contact: Lisa Conboy, 617-718-1917, [email protected]
10 Study Locations in 1 Countries
California
University of California, Berkeley, Berkeley, California, 94720, United States
Irina Conboy, PhD, Contact
Not yet recruiting
Various, Los Angeles, California, 90015, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Recruiting
Colorado
Various, Colorado Springs, Colorado, 80911, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Not yet recruiting
Various, Denver, Colorado, 80203, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Not yet recruiting
Florida
Various, Tampa, Florida, 33762, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Recruiting
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Lisa A Conboy, MA MS ScD, Contact, 617-718-1917, [email protected]
Not yet recruiting
Texas
Various, Dallas, Texas, 75231, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Recruiting
Utah
University of Utah, Salt Lake City, Utah, 84111, United States
Lisa Taylor-Swanson, Contact, [email protected]
Not yet recruiting
Virginia
Various, Fairfax, Virginia, 23235, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Not yet recruiting
Washington
Various, Seattle, Washington, 98116, United States
CARE Study Research Team, Contact, 801-646-8308, [email protected]
Not yet recruiting