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

NCT01338701 | Completed Phase 2

• 1 other identifier: 350890
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Headache; Traumatic Brain Injury

Keywords

TBI; Headaches; Military; Acupuncture; Walter Reed Army Medical Center; Fort Belvoir Community Hospital

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Headache Impact Test at Week 6

  This is a 6-item measure that assesses headache severity. This will take approximately 1 minute to complete.

  Baseline, Week 6, Week 12

Secondary Outcomes (10)

• Daily Headache Diary

  Completed daily for 6 weeks

• Change from Baseline in Numerical Rating Scale at Week 6

  Baseline, Week 6

• Change from Baseline in Beck Depression Inventory at Week 6

  Baseline, Week 6

• Change from Baseline in State-Trait Anxiety Inventory at Week 6

  Baseline, Week 6

• Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6

  Baseline, Week 6

Study Arms (3)

Auricular (Ear) Acupuncture

EXPERIMENTAL

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.

Procedure: Auricular (Ear) Acupuncture

Traditional Chinese Acupuncture (TCA)

EXPERIMENTAL

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.

Procedure: Traditional Chinese Acupuncture (TCA)

Usual Care

OTHER

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

Other: Usual Care

Interventions

Traditional Chinese Acupuncture (TCA) 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.

Traditional Chinese Acupuncture (TCA)

Auricular (Ear) Acupuncture 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.

Auricular (Ear) Acupuncture

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Samueli Institute for Information Biology: lead
• Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Fort Belvoir Community Hospital

Alexandria, Virginia, 22060, United States

Location

MeSH Terms

Conditions

Headache; Brain Injuries, Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Louis M French, PsyD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

• Heechin Chae, MD

  Fort Belvoir Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: April 19, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)