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

NCT01338701 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-05-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury

    collaborator FED

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Samueli Institute for Information Biology

    lead OTHER

Principal Investigators

  • Louis M French, PsyD · Walter Reed Army Medical Center

  • Heechin Chae, MD · Fort Belvoir Community Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338701 on ClinicalTrials.gov