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

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.

Study Overview

• Status: Completed
• Conditions: Headache; Traumatic Brain Injury
• Intervention / Treatment: Procedure: Auricular (Ear) Acupuncture; Procedure: Traditional Chinese Acupuncture (TCA); Other: Usual Care

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20307
      • Walter Reed Army Medical Center
  • Virginia
    • Alexandria, Virginia, United States, 22060
      • Fort Belvoir Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Other: Usual Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Headache Diary	Before bedtime, participants will note whether or not they had a headache that day. If they experienced a headache, they will rate it's severity and whether or not they took any medications for the headache. It takes less than a minute to complete.	Completed daily for 6 weeks
Change from Baseline in Numerical Rating Scale at Week 6	This assesess pain along a 0-10 scale. It takes less than a minute to complete.	Baseline, Week 6
Change from Baseline in Beck Depression Inventory at Week 6	This is a 21-question inventory that rates depressive symptoms. It takes approximately 5 minutes to complete.	Baseline, Week 6
Change from Baseline in State-Trait Anxiety Inventory at Week 6	This is a 40-item survey that measures anxiety symptoms. It takes approximately 5 minutes to complete.	Baseline, Week 6
Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6	Participants will indicate the degree to which they have experienced PTSD symptoms on a 5-point scale during the past month. It takes approximately 5 minutes to complete.	Baseline, Week 6
Change from Baseline in Symptom Checklist 90-R at Week 6	This is a 90-item checklist that evaluates a broad range of symptoms and psychological symptoms. It takes approximately 15 minutes to complete.	Baseline, Week 6
Change from Baseline in Medical Outcome Study Quality of Life at Week 6	This measure evaluates physical and psychological functioning. It takes approximately 10 minutes to complete.	Baseline, Week 6
Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6	This measure evaluates cognitive function and takes approximately 30 minutes to complete.	Baseline, Week 6
Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6	This measure evaluates sleep quality and disturbances over athe past month. It takes approximately 7 minutes to complete.	Baseline, Week 6
Change from Baseline in Expectancy Scale at Week 6	This measures participants' pre-conceived expectations about the effect of acupuncture on headaches. It takes less than a minute to complete.	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Samueli Institute for Information Biology
• Collaborators: U.S. Army Medical Research and Development Command; Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
• Investigators: Principal Investigator: Louis M French, PsyD, Walter Reed Army Medical Center; Principal Investigator: Heechin Chae, MD, Fort Belvoir Community Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Acupuncture; TBI; Military; Headaches; Walter Reed Army Medical Center; Fort Belvoir Community Hospital
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Headache
• Other Study ID Numbers: 350890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be shared in a published manuscript.