Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
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| ClinicalTrials.gov Identifier: NCT01060553 |
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Recruitment Status :
Completed
First Posted : February 2, 2010
Results First Posted : November 19, 2014
Last Update Posted : April 28, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-traumatic Stress Disorders | Other: Acupuncture treatment | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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.
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- SF-36 [ Time Frame: baseline, 6 or 12 weeks (latest available is used) ]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.
- Pittsburgh Sleep Index [ Time Frame: baseline, 6 or 12 weeks (latest available is used) ]subscales range from 0 to 3 with higher being worse.
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| Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060553
| United States, New Jersey | |
| East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ | |
| East Orange, New Jersey, United States, 07018 | |
| Principal Investigator: | Thomas W Findley, MD PhD | East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ |
| Responsible Party: | US Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01060553 |
| Other Study ID Numbers: |
PPO 09-258 |
| First Posted: | February 2, 2010 Key Record Dates |
| Results First Posted: | November 19, 2014 |
| Last Update Posted: | April 28, 2015 |
| Last Verified: | August 2014 |
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Post-traumatic stress disorders Acupuncture Quality of life sleep disorder |
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Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |