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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01338701
Study type Interventional
Source Samueli Institute for Information Biology
Contact
Status Completed
Phase Phase 2/Phase 3
Start date February 2011
Completion date April 2015
View Details
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