Acupuncture for TBI Headaches 

Project Title:

A Comparative Effectiveness Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated with Traumatic Brain Injury (TBI)

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Project Overview:

This randomized controlled exploratory study seeks to determine if standardized ear acupuncture or semi-standardized Traditional Chinese acupuncture (TCA) alleviates headaches more effectively than usual care alone in a cohort of active duty military with TBI and associated headaches. Study participants are Service Members who have been diagnosed with mild to moderate TBI and are experiencing headaches. After an initial screening visit to determine eligibility and obtain informed consent, participants are randomized to one of three groups: ear acupuncture, TCA, or usual care alone. Study participants randomized to either acupuncture group will continue to receive usual care in addition to receiving 10 acupuncture treatments over six weeks.

In addition to the primary outcome of headache-related quality of life, this study compares the effectiveness of these two acupuncture approaches on symptoms associated with TBI, including pain, depression, anxiety, post-traumatic stress disorder (PTSD) symptoms, somatic dysfunction, physical functioning, cognitive function and sleep quality. 

We hypothesize that both auricular and TCA acupuncture will decrease headache scores compared to the usual care group, and that co-morbid symptoms will change in a favorable direction in the TCA acupuncture group as compared to the usual care group.

There is substantial evidence that acupuncture may reduce headache and pain as well as facilitate recovery across numerous trauma spectrum symptoms in TBI patients, possibly at a lower cost than usual care and with little risk of producing side effects. If found to be effective, one or both of these acupuncture methods could have widespread applicability as a safe and easily administered non-pharmacologic treatment for TBI-associated headaches in a military population. 

Status:

Closed. Data analysis in process.

Partnerships:

This is a collaborative study between the Walter Reed National Military Medical Center Traumatic Brain Injury Program and Samueli Institute.

This work is supported by the US Army Medical Research and Materiel Command under Award Numbers:

W81XWH-08-2-0212
W81XWH-11-2-0173
W81XWH-08-1-0408
W81XWH-11-1-0759
W81XWH-10-1-0820
W81XWH-07-2-0076
W81XWH-06-1-0279
W81XWH-06-2-0009
W81XWH-10-1-1011
W81XWH-10-2-0184
W81XWH-08-1-0615
W81XWH-10-1-0938
W81XWH-11-1-0538

The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.

In the conduct of research where humans are the subjects, the investigator(s) adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).