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Acupuncture in the Treatment of Gulf War Illness

Acupuncture in the Treatment of Gulf War Illness

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01305811
Enrollment
104
Registered
2011-03-01
Start date
2009-07-31
Completion date
2013-01-31
Last updated
2015-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persian Gulf Syndrome

Keywords

Complex Medical Illness, Gulf War Illness, Veteran

Brief summary

This unblinded Phase II clinical trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

Detailed description

Gulf War Illness (GWI) is a complex, poorly understood illness characterized by many symptoms, including fatigue after exertion, sleep and mood problems, difficulty concentrating, difficulty thinking and finding words, and musculoskeletal pain. Individuals often present with many symptoms, some of them severe and disabling, and with additional medical diagnoses, including chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome, digestive complaints, and mood-related psychiatric disorders, such as depression, posttraumatic stress disorder, and other anxiety disorders. More than 100,000 veterans of the first Gulf War (Operation Desert Shield/Storm, 1990-1991) out of 700,000 US service personnel deployed to the Persian Gulf have presented with medical complaints through programs established to address the problem, which came to be called chronic multisymptom illness (CMI). Groups of veterans in the United Kingdom, Canada, and Australia have been identified with similar problems. The veterans have received treatment directed at their symptoms, but at 5- and 10-year follow-ups, many reported their symptoms remained, some of them severe and disabling. Clearly, an effective treatment for these conditions would be of great benefit to those who were injured during their military service. The cause of CMI is unknown, and the symptoms can not be explained by physical and laboratory examinations. Several factors have been considered, including exposure to vaccines, chemicals likely to be encountered in combat (chemical weapons, smoke, pesticides) and stress related to military service, deployment, and combat. After investigation by the Centers for Disease Control (CDC), researchers suspect that the symptoms reflect a range of injuries to the nervous system. It may be that the factors that led to these injuries were not specific to the Persian Gulf region, and that veterans of the current war in Iraq and Afghanistan, as well as active duty personnel, are exposed to similar stressors and will benefit from an investigation of CMI and its treatment. The goal of this study is to help identify whether acupuncture is an effective treatment for Gulf War Syndrome. Acupuncture is likely to be helpful in treating GWI because it has already been used successfully to reduce many of its key symptoms - fatigue, irritability, anxiety, insomnia, and pain. Acupuncture treatment is designed to treat each individual's symptoms making it very well suited for treating the varied symptoms of GWI. Veterans will receive care that is directed specifically at their most distressing symptom. Although the specific etiology of CMI is unknown, acupuncture's analgesic and anti-inflammatory effects are likely to be helpful. Acupuncture seems to work, in part, on peripheral nerves near the site of injury, in the brain, central nervous system, and on the endocrine system, in ways that promote the body's own efforts to reduce pain and heal even chronic injuries. Numerous studies have shown acupuncture is well tolerated by patients, safe, and cost-effective compared to routine care. Acupuncture will be provided by licensed acupuncturists with at least 5 years of clinical experience, who have received 20-hours of training related to symptoms of GWI. Subjects were recruited via local advertisements and direct mailing to veterans on the Defense Manpower Data Center (http://www.virec.research.va.gov/Non-VADataSources/DMDC.htm). Through questionnaires, physician assessment, and medical histories, the investigators measured the severity of symptoms before beginning treatment, and after 2, 4 and 6 months of treatment. One group of patients received acupuncture evaluation and treatment twice per week for 6 months. A second group, for comparison purposes, will be monitored on a wait list for 2 months, and will then be offered weekly acupuncture for 4 months. Based on previous acupuncture research on fatigue, stress, and pain, the investigators expect this length of treatment will be enough for patients to receive significant benefit. The investigators also planed to collect samples of blood from our volunteers that will help identify possible disease mechanisms for the illness and track the effects of treatment.

Interventions

DEVICEAcupuncture

Sterile insertive needles are applied by licensed, experienced practitioners.

Sponsors

United States Department of Defense
CollaboratorFED
New England School of Acupuncture
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
39 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion 1. 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, 2. they 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 or * feeling irritable or * difficulty thinking or concentrating or * feeling worried, tense, anxious or * problems finding words or * problems getting to sleep C-Musculoskeletal * joint pain or muscle pain Exclusion: * 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

Design outcomes

Primary

MeasureTime frameDescription
SF-36P6 monthsTen 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.

Other

MeasureTime frameDescription
SF-36P2 monthsTen 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Bi-weekly Acupuncture Treatment
Bi-weekly acupuncture treatment for 6 months
52
Wait List
Wait list for 2 months then weekly acupuncture for four months
52
Total104

Baseline characteristics

CharacteristicWait ListBi-weekly Acupuncture TreatmentTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
52 Participants52 Participants104 Participants
Age, Continuous48.2 years
STANDARD_DEVIATION 3.5
48.2 years
STANDARD_DEVIATION 9.9
48.2 years
STANDARD_DEVIATION 6.7
Region of Enrollment
United States
52 participants52 participants104 participants
Sex: Female, Male
Female
7 Participants7 Participants14 Participants
Sex: Female, Male
Male
45 Participants45 Participants90 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 520 / 52
serious
Total, serious adverse events
1 / 520 / 52

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureValue (MEAN)
Bi-Weekly AcupunctureSF-36P73.7 units on a scale
Wait List Then Weekly AcupunctureSF-36P64.3 units on a scale
p-value: 0.03general estimating equations
Other Pre-specified

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.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Bi-Weekly AcupunctureSF-36P0.32 units on a scaleStandard Deviation 16.8
Wait List Then Weekly AcupunctureSF-36P4.53 units on a scaleStandard Deviation 14.8
Comparison: In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student's t-tests at an alpha=0.05.p-value: =0.22t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026