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 20, 2015
Last verified: May 2015
Results First Received: September 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Persian Gulf Syndrome
Intervention: Device: Acupuncture

  Participant Flow
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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
  Description
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  
NOT COMPLETED     8     11  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  52     52     104  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     52     52     104  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  48.2  (9.9)     48.2  (3.5)     48.2  (6.7)  
Gender  
[units: participants]
     
Female     7     7     14  
Male     45     45     90  
Region of Enrollment  
[units: participants]
     
United States     52     52     104  



  Outcome Measures
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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
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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
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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
e-mail: lconboy@nesa.edu


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
Results First Received: September 29, 2014
Last Updated: May 20, 2015
Health Authority: United States: Federal Government