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PPO 09-258 – HSR&D Study

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PPO 09-258
Pilot of Acupuncture to improve quality of life in veterans with TBI and PTSD
Thomas W Findley MD PhD
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, NJ
Funding Period: July 2010 - September 2011

BACKGROUND/RATIONALE:
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, ameliorating stress and anxiety, insomnia, somatic and post-operative pain and, recently, PTSD, with studies finding 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.

OBJECTIVE(S):
The overall objective for this pilot project was 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 was: 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.

METHODS:
This was a pilot randomized study on veterans who screen positive for 2, 3 or 4 factors on the PTSD screen in the VA healthcare record. Acupuncture treatments were twice a week for 12 weeks, following the protocol established by Hollifield (J Nerv Ment Dis. 2007;195:504-513). It combined front and back treatments to avoid point fatigue (tolerance due to frequent use).The front treatment used 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 were 15 other points which were flexibly chosen.

A list of 4200 veterans with PTSD screen >=2 was generated from CPRS, and divided by male/female and age above/below 40. 970 names were drawn randomly from this list, from each of the four demographic groups. Names were then screened for those who were OIF/OEF. 349 recruitment letters were sent to these veterans, which were followed up by two phone calls. 127 veterans were reached via phone; 86, or 68% expressed interest in participating . A randomized block design resulted in 16 veterans assigned to immediate treatment, while 15 were assigned to a wait list. Barriers to enrollment and completion of the study were distance to our center and duration and scheduling, even though we offered evening treatment hours.

We assessed outcomes at baseline, midpoint and completion. Key variables were: PCLC score, and VSF-36 score, with secondary measures of AUDIT, Pain, Sleep, Headache, and SCL90.


FINDINGS/RESULTS:
10 subjects completed either the midpoint or the completion assessment. Since the data from these two groups showed similar changes, they are combined here. The pre and post scores for the immediate treatment and wait list are also combined. Despite the small sample size, paired T test showed significant changes from pre to post acupuncture. Sleep disturbance decreased from 2.4 to 1.7 (p<.001) and sleep latency from 2.6 to 1.7 (p<.015).

Most SCL90 subscales decreased by about 25% with three being significant: somatization 1.56 to 1.20 (P<.013), phobic anxiety 1.08 to .66 (p< .042), psychoticism .90 to .59 (p<.013). Headaches were reported as substantial or severe impact, with little change. Our results found a moderate effect size of 30 to 50% of the standard deviation for the other variables, which showed a trend but were not statistically significant. SF36 MCS increased from 35.2 to 39.0, PCS from 41.8 to 44.5; PCLC decreased from 53 to 48.3.

IMPACT:
Acupuncture may be useful in management of multiple symptoms experienced by veterans with PTSD, particularly sleep disturbance. However the scheduling of treatment sessions needs to take into account veteran preferences and time schedules.

PUBLICATIONS:

Conference Presentations

  1. Rusiewicz A, Ray KG, Strong J, Maney M, Marki M, Chandler H, Findley TW. Lessons Learned: Recruiting for a Pilot Study of Acupuncture to Improve Quality of Life in Veterans with PTSD. Poster session presented at: VA WRIISC Caring for Veterans with Post Deployment Health Concerns: Past, Present and Future Conference; 2011 Aug 9; Washington, DC.


DRA: Military and Environmental Exposures, Mental, Cognitive and Behavioral Disorders, Brain and Spinal Cord Injuries and Disorders, Health Systems, Acute and Combat-Related Injury
DRE: Treatment - Observational, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Complementary & alternative therapy, Complementary and Alternative Practices, PTSD, Traumatic Brain Injury
MeSH Terms: none