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Acupuncture in the Treatment of Gulf War Illness

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ClinicalTrials.gov Identifier: NCT01305811
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : May 21, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
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
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bi-weekly Acupuncture Treatment Wait List
Hide Arm/Group Description Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments. Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
Period Title: Overall Study
Started 52 52
Completed 44 41
Not Completed 8 11
Arm/Group Title Bi-weekly Acupuncture Treatment Wait List Total
Hide Arm/Group Description Bi-weekly acupuncture treatment for 6 months Wait list for 2 months then weekly acupuncture for four months Total of all reporting groups
Overall Number of Baseline Participants 52 52 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
52
 100.0%
104
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 104 participants
48.2  (9.9) 48.2  (3.5) 48.2  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Female
7
  13.5%
7
  13.5%
14
  13.5%
Male
45
  86.5%
45
  86.5%
90
  86.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 52 participants 104 participants
52 52 104
1.Primary Outcome
Title SF-36P
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-Weekly Acupuncture Wait List Then Weekly Acupuncture
Hide Arm/Group Description:
group mean SF-36 P score at 6 months
group mean SF-36 P score at 6 months
Overall Number of Participants Analyzed 44 41
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
73.7
(67.7 to 79.8)
64.3
(57.1 to 71.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bi-Weekly Acupuncture, Wait List Then Weekly Acupuncture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method general estimating equations
Comments [Not Specified]
2.Other Pre-specified Outcome
Title SF-36P
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-weekly Acupuncture Treatment Wait List
Hide Arm/Group Description:

Bi-weekly acupuncture treatment

Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners.

Wait list for 2 months.

Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners.

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.32  (16.8) 4.53  (14.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bi-weekly Acupuncture Treatment, Wait List
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.22
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 years 5 months
Adverse Event Reporting Description All potential adverse events which occurred in either study arm were reviewed by the study's medical monitor. Serious and/or unexpected events were reported to the Main IRB and the funder's review office (Army Human Research Protection Office (HRPO)).
 
Arm/Group Title Bi-Weekly Acupuncture Wait List
Hide Arm/Group Description

Bi-Weekly Acupuncture for 6 months

1 serious unexpected adverse event in the biweekly group: Subject’s practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter’s custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized.

The practitioner will also follow up with subject’s PCP.

Wait list for 2 months followed by 4 months of weekly acupuncture

No Adverse events were reported in the Wait list group

All-Cause Mortality
Bi-Weekly Acupuncture Wait List
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bi-Weekly Acupuncture Wait List
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/52 (1.92%)      0/52 (0.00%)    
Social circumstances     
Serious unexpected  [1]  1/52 (1.92%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Subject’s practitioner was told by subject of a suicide attempt.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bi-Weekly Acupuncture Wait List
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/52 (1.92%)      0/52 (0.00%)    
Social circumstances     
Pain on needling  [1]  1/52 (1.92%)  52 0/52 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Subject is experiencing pain at one of the acupuncture points that was needled and this pain has lasted longer than is typical.
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
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)
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