Acupuncture in the Treatment of Gulf War Illness

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Conboy, New England School of Acupuncture
ClinicalTrials.gov Identifier:
NCT01305811
First received: February 24, 2011
Last updated: May 18, 2015
Last verified: May 2015
  Purpose

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).


Condition Intervention Phase
Persian Gulf Syndrome
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:
  • SF-36P [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • SF-36P [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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. 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.


Enrollment: 104
Study Start Date: July 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-weekly acupuncture treatment
Bi-weekly acupuncture treatment
Device: Acupuncture
Sterile insertive needles are applied by licensed, experienced practitioners.
Active Comparator: Wait list
Wait list for 2 months followed by weekly acupuncture for 4 months
Device: Acupuncture
Sterile insertive needles are applied by licensed, experienced practitioners.

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.

  Eligibility

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

Locations
United States, Massachusetts
New England School of Acupuncture
Newton, Massachusetts, United States, 02458
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, Director of Research, 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
Results First Received: September 29, 2014
Last Updated: May 18, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on May 21, 2015