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Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01060553
First received: January 29, 2010
Last updated: November 7, 2014
Last verified: November 2014

January 29, 2010
November 7, 2014
July 2010
December 2011   (final data collection date for primary outcome measure)
SF-36 [ Time Frame: baseline, 6 or 12 weeks (latest available is used) ] [ Designated as safety issue: No ]
global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.
SF-36 physical and mental function scores [ Time Frame: baseline, 12 weeks, 3 months post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01060553 on ClinicalTrials.gov Archive Site
Pittsburgh Sleep Index [ Time Frame: baseline, 6 or 12 weeks (latest available is used) ] [ Designated as safety issue: No ]
subscales range from 0 to 3 with higher being worse.
Not Provided
Not Provided
Not Provided
 
Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study will also examine the degree of veteran acceptance for acupuncture.

Project Background: Acupuncture can be effective for many of the specific co-morbidities that make up war-related Trauma Spectrum Disorder in both TBI and PTSD patients, including pain, stress and anxiety, insomnia, somatic and post-operative pain. Recent studies find very large effect sizes (Cohen's D .85 to 1.4). Thus, there is good reason to believe that acupuncture will induce recovery across a number of trauma spectrum dysfunctions in patients with TBI and PTSD, at low cost and with little risk.

Project Objectives: The overall objective of this application is to determine the efficacy of adjunctive acupuncture for improving quality of life and function and alleviating co-morbidities associated with TBI and PTSD in service members injured in the current wars. The primary hypothesis of this study is: OIF/OEF veterans who screen positive for TBI or PTSD and are treated with a 12 week standard individualized acupuncture method will experience improved HRQL (as measured by the Veteran's SF-36) at 6, 12 and 24 week follow-up, compared to veterans randomly assigned to standard care alone.

Project Methods: This is a pilot study on veterans who screen positive for TBI or PTSD in the VA healthcare record, which is being submitted to obtain additional pilot data, confirmation of recruitment strategies, and information on non-participants . Frequency distribution and summary statistics for demographics and baseline variables will be presented by intervention group and for all subjects combined. Key demographic variables to be summarized are: age, gender, time to deployment, number of deployments, and diagnosis. Key baseline variables are: PTSD CAPS score, VSF-36, and ANAM score.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-traumatic Stress Disorders
Other: Acupuncture treatment
This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment. Due to the very small number of subjects in the wait list control, the ones who completed 6 or 12 weeks of acupuncture after the wait list were combined with the few who completed the initial acupuncture for a pre-post single group analysis. for those who completed both the 6 and 12 week measures, the latest one was selected for analysis
  • Experimental: Arm 1
    The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
    Intervention: Other: Acupuncture treatment
  • No Intervention: wait list control
    subjects were put on a wait list control. due to small numbers completing in both groups, the data from the wait list who completed acupuncture are combined with the experimental treatment group for analysis.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis or positive screen test for PTSD.
  • Combat veterans of Operation Iraqi Freedom or Operation Enduring Freedom conflicts.

Exclusion Criteria:

  • Unable to travel to East Orange VA for 12 consecutive weeks, biweekly for treatment.
  • Does not speak English.
  • Acupuncture or CBT treatment within the previous six months.
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01060553
PPO 09-258
No
Department of Veterans Affairs
Department of Veterans Affairs
Samueli Institute for Information Biology
Principal Investigator: Thomas W Findley, MD PhD VA New Jersey Health Care System
Department of Veterans Affairs
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP