Pilot of Acupuncture to Improve Quality of Life in Veterans With Traumatic Brain Injury (TBI) and Post-Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01060553
First received: January 29, 2010
Last updated: April 16, 2014
Last verified: April 2014

January 29, 2010
April 16, 2014
July 2010
December 2011   (final data collection date for primary outcome measure)
SF-36 physical and mental function scores [ Time Frame: baseline, 12 weeks, 3 months post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01060553 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot of Acupuncture to Improve Quality of Life in Veterans With Traumatic Brain Injury (TBI) and Post-Traumatic Stress Disorder (PTSD)
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.

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, information on non-participants and larger geographic coverage by including sites where the PI already has multisite collaborations. 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. This two arm pilot study will lead to a multisite study.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Post-traumatic Stress Disorders
  • Traumatic Brain Injury
Other: Acupuncture treatment
Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy or life force - known as qi or chi - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used. For example, for an acupuncture treatment on the back, the needles would be inserted at the base of the neck, upper back, middle back and lower back.
  • Experimental: Arm 1
    acupuncture
    Intervention: Other: Acupuncture treatment
  • No Intervention: Arm 2
    standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis or positive screen test for PTSD and/or TBI.
  • 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.
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01060553
PPO 09-258
No
Department of Veterans Affairs
Department of Veterans Affairs
Samueli Institute for Information Biology
Principal Investigator: Thomas W Findley, MD PhD VA New Jersey Health Care System
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP