Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI

Completed · Phase 2/Phase 3

Conditions studied: Headache, Traumatic Brain Injury

In brief

This study investigates whether acupuncture can help to decrease the number and severity of headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two different types of acupuncture-either Traditional Chinese Acupuncture or ear acupuncture-to a group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain, improve health-related quality of life, prevent migraine headaches, and improve tension and chronic daily headaches.

Key facts

Study ID

NCT01338701

Run by

Samueli Institute for Information Biology

People needed

45

Starts

2011-02-01

Expected to finish

2015-04-01

Last updated by the study team

2016-05-13

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-69 years of age
• Service Members with previous deployment to war zone
• Non-acute mild to moderate traumatic brain injury as defined by:
• Injury event (i.e., blast, fall, MVC, head impact) that occurred at least 7 days prior
• Loss of consciousness (if present) for less than 24 hours and alteration of consciousness or posttraumatic amnesia for less than one week
• Presence of headache or any etiology requiring self-medication or medical management with at least 4 headache days in the past 4 weeks
• Rancho Los Amigos Cognitive Scale score of greater than or equal to 7
• Able to provide informed consent

You may not qualify if…

• Acupuncture treatment for any reason within the past month
• Any active unstable psychiatric condition, including active psychosis, suicidal or homicidal ideation
• Unwillingness on the part of the participant to complete all study visits and/or components of the intervention
• Scheduled surgery during the treatment phase of the study
• Pregnancy or breastfeeding at time of study enrollment or during study participation
• Any medically unstable condition that in the opinion of the P.I. has the potential to warrant inpatient treatment in the medical or intensive care units
• Inability to give informed consent or complete study measures

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Fort Belvoir Community Hospital — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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