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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorders
• Intervention / Treatment: Other: Acupuncture treatment

Detailed Description

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
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	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.	baseline, 6 or 12 weeks (latest available is used)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Index	subscales range from 0 to 3 with higher being worse.	baseline, 6 or 12 weeks (latest available is used)

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Collaborators: Samueli Institute for Information Biology
• Investigators: Principal Investigator: Thomas W Findley, MD PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Acupuncture; Quality of life; sleep disorder; Post-traumatic stress disorders
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: PPO 09-258