Acupuncture in the Treatment of Gulf War Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305811
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : May 21, 2015
Last Update Posted : June 15, 2015
United States Department of Defense
Information provided by (Responsible Party):
Lisa Conboy, New England School of Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Persian Gulf Syndrome
Intervention: Device: Acupuncture

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Bi-weekly Acupuncture Treatment Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.
Wait List Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.

Participant Flow:   Overall Study
    Bi-weekly Acupuncture Treatment   Wait List
STARTED   52   52 
COMPLETED   44   41 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Bi-weekly Acupuncture Treatment Bi-weekly acupuncture treatment for 6 months
Wait List Wait list for 2 months then weekly acupuncture for four months
Total Total of all reporting groups

Baseline Measures
   Bi-weekly Acupuncture Treatment   Wait List   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   52   104 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   52   52   104 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 48.2  (9.9)   48.2  (3.5)   48.2  (6.7) 
[Units: Participants]
Female   7   7   14 
Male   45   45   90 
Region of Enrollment 
[Units: Participants]
United States   52   52   104 

  Outcome Measures

1.  Primary:   SF-36P   [ Time Frame: 6 months ]

2.  Other Pre-specified:   SF-36P   [ Time Frame: 2 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Lisa Conboy
Organization: New England School of Acupuncture
phone: 6175581788 ext 145

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Lisa Conboy, New England School of Acupuncture Identifier: NCT01305811     History of Changes
Other Study ID Numbers: GW080059(W81XWH-09-2-0064)
First Submitted: February 24, 2011
First Posted: March 1, 2011
Results First Submitted: September 29, 2014
Results First Posted: May 21, 2015
Last Update Posted: June 15, 2015