NCT01338701

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

A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Samueli Institute for Information Biology · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a 12 week study. If eligible, participants will be randomly assigned to 1of 3 groups: ear acupuncture, Traditional Chinese Acupuncture, or the usual care group. Subjects receiving acupuncture will: * meet with one of the acupuncturists who will conduct her first assessment * come to Walter Reed Army Medical Center (WRAMC) 10 times over a 6-week period to receive acupuncture treatments from a licensed acupuncturist Subjects in the usual care group will: * not receive any acupuncture treatments * continue usual treatment plan * be given the option to receive 10 acupuncture treatments between the 6- and 12-week period All subjects will also: * complete questionnaires at 3 different times: baseline (beginning of study), after 6 weeks, and after 12 weeks. These questionnaires will assess headaches, overall health and quality of life * complete a daily headache diary * continue to be treated for their headaches * continue taking prescription and over-the-counter medications for any conditions being treated

Conditions

• Headache
• Traumatic Brain Injury

Interventions

Type	Name	Description
PROCEDURE	Traditional Chinese Acupuncture (TCA)	An acupuncturist will examine and evaluate subjects before inserting thin, sterile stainless steel needles at specific points on their body. Patients will receive 10 treatments over a 6 week period.
PROCEDURE	Auricular (Ear) Acupuncture	An acupuncturist will insert sterile stainless steel needles and an ASP ear needle into various points in subject's outer ear. The ASP is a shorter needle that will stay in the participant's ear for a few days. Patients will receive 10 treatments over a 6 week period.
OTHER	Usual Care	Subjects do not receive acupuncture during the 6 week study time period. Instead, they continue to receive medical care for headaches and other symptoms. They can elect to receive up to 10 ear acupuncture treatments between the 6- and 12-week assessments.

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-04-19
• Last updated: 2016-05-13

Locations

2 sites across 1 country: United States