Skip to main content
OpenTrials
Completed

NCT Number: NCT01060553

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-Traumatic Stress Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

East Orange, New Jersey, 07018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture treatment

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pittsburgh Sleep Index

    Time frame: baseline, 6 or 12 weeks (latest available is used)

    subscales range from 0 to 3 with higher being worse.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Samueli Institute for Information Biology

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2010
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.