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

NCT ID: NCT01338701

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Auricular (Ear) Acupuncture

Auricular (Ear) Acupuncture is administered in a step-wise, algorithmic acupuncture approach in which needles are inserted at specific auricular landmarks. The sequence and location of needled points is determined by the participant's severity of headache pain at presentation and response to needling. Between six and nine points are needled in each treatment session depending on the individual's response (i.e., a decrease or persistence of headache pain). In-dwelling ASP needles are inserted at the end of each session. Participants are instructed to remove the needles after 3 days, or sooner if pain or redness developed at a needle site. Ten 45-minute acupuncture treatment sessions are administered over 6 weeks.

Group Type: EXPERIMENTAL

Auricular (Ear) Acupuncture

Intervention Type: PROCEDURE

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.

Traditional Chinese Acupuncture (TCA)

A semi-standardized form of Traditional Chinese Acupuncture (TCA) is administered, incorporating the insertion of up to 22 acupuncture needles associated with each individual participant's: (1) primary headache pattern (up to three pairs of points); (2) secondary headache pattern (up to 2 pairs of points); (3) Ah-Shi or tender points (up to 4 points); (4) constitutional points (source points on two meridians); and, (5) up to 2 pairs of additional points from a selected list. Point selection was reassessed every two weeks per TCM diagnostic and treatment principles. While the majority of points were located on the limbs, points also included local points of tenderness to the head, as well as the front and back of the torso. Ten 60-minute TCA sessions are administered over 6 weeks.

Group Type: EXPERIMENTAL

Traditional Chinese Acupuncture (TCA)

Intervention Type: PROCEDURE

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.

Usual Care

All study participants continue to receive routine usual care for their TBI, headaches and associated symptoms as determined by their clinical team.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 18-69 years of age

2. Service Members with previous deployment to war zone

3. 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

4. Presence of headache or any etiology requiring self-medication or medical management with at least 4 headache days in the past 4 weeks

5. Rancho Los Amigos Cognitive Scale score of greater than or equal to 7

6. Able to provide informed consent

Exclusion Criteria

1. Acupuncture treatment for any reason within the past month

2. Any active unstable psychiatric condition, including active psychosis, suicidal or homicidal ideation

3. Unwillingness on the part of the participant to complete all study visits and/or components of the intervention

4. Scheduled surgery during the treatment phase of the study

5. Pregnancy or breastfeeding at time of study enrollment or during study participation

6. 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

7. Inability to give informed consent or complete study measures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Samueli Institute for Information Biology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis M French, PsyD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Heechin Chae, MD

Role: PRINCIPAL_INVESTIGATOR

Fort Belvoir Community Hospital

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Fort Belvoir Community Hospital

Alexandria, Virginia, United States

Countries

United States

Other Identifiers

350890

Identifier Type: -

Identifier Source: org_study_id