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

NCT ID: NCT01060553

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Post-traumatic Stress Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Acupuncture treatment

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samueli Institute for Information Biology

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas W Findley, MD PhD

Role: PRINCIPAL_INVESTIGATOR

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Locations

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, United States

Countries

United States

Other Identifiers

PPO 09-258

Identifier Type: -

Identifier Source: org_study_id