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Acupuncture in the Treatment of Gulf War Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by New England School of Acupuncture.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
New England School of Acupuncture
ClinicalTrials.gov Identifier:
NCT01305811
First received: February 24, 2011
Last updated: February 25, 2011
Last verified: February 2011
  Purpose

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 were 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 (CDCP), 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. Though 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.

The investigators plan to recruit patients through the Department of Veterans Affairs (VA) who report they have symptoms of GWI. Through questionnaires, physician assessment and medical histories, the investigators will measure the severity of symptoms before beginning treatment, after 2 months, and after treatment is completed. One group of patients will receive acupuncture evaluation and treatment twice per week for 2 months, followed by once per week for 4 months. A second group, for comparison purposes, will continue whatever treatment they received from their physicians, and will be offered acupuncture after waiting for 2 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 plan to collect samples of blood and saliva from our volunteers that will help identify possible disease mechanisms for the illness and track the effects of treatment.


Condition Intervention Phase
Veterans With Gulf War Illness
Device: Acupuncture
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture in the Treatment of Gulf War Illness

Resource links provided by NLM:


Further study details as provided by New England School of Acupuncture:

Primary Outcome Measures:
  • Statistically significant changes in Sf-36 scores at 2 months of treatment. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    A short-form health survey with 36 questions


Estimated Enrollment: 120
Study Start Date: July 2009
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-weekly acupuncture treatment
Bi-weekly acupuncture treatment
Device: Acupuncture
Bi-weekly acupuncture
Active Comparator: Wait list
Wait list
Device: Acupuncture
Bi-weekly acupuncture

  Eligibility

Ages Eligible for Study:   39 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gulf War Illness Symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305811

Contacts
Contact: Lisa A Conboy, ScD 617 558 1788 ext 145 lconboy@nesa.edu
Contact: Denise Rouleau, BA 617 558 1788 ext 123 DRouleau@nesa.edu

Locations
United States, Massachusetts
New England School of Acupuncture Recruiting
Newton, Massachusetts, United States, 02458
Contact: Lisa A Conboy, ScD    617-558-1788 ext 145    lconboy@nesa.edu   
Contact: Denise Rouleau, BA    617 558 1788 ext 123    DRouleau@nesa.edu   
Sponsors and Collaborators
New England School of Acupuncture
Investigators
Principal Investigator: Lisa A Conboy, ScD New England School of Acupuncture
  More Information

Additional Information:
No publications provided

Responsible Party: Lisa Conboy, New England School of Acupuncture
ClinicalTrials.gov Identifier: NCT01305811     History of Changes
Other Study ID Numbers: GW080059(W81XWH-09-2-0064)
Study First Received: February 24, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board
United States: Department of Defense

Keywords provided by New England School of Acupuncture:
Complex Medical Illness
Gulf War Illness
Veteran

ClinicalTrials.gov processed this record on November 25, 2014