Clinical trial NCT01338701: Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI
Official title: A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Headache
Traumatic Brain Injury
Keywords: TBI
Headaches
Military
Acupuncture
Walter Reed Army Medical Center
Fort Belvoir Community Hospital
Lead sponsor: Samueli Institute for Information Biology
Sponsor class: OTHER
Collaborators: name: Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
name: U.S. Army Medical Research and Development Command
First posted: 2011-04-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from Baseline in Headache Impact Test at Week 6
timeFrame: Baseline, Week 6, Week 12
Secondary outcomes:
measure: Daily Headache Diary
timeFrame: Completed daily for 6 weeks
measure: Change from Baseline in Numerical Rating Scale at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Beck Depression Inventory at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in State-Trait Anxiety Inventory at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Symptom Checklist 90-R at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Medical Outcome Study Quality of Life at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Expectancy Scale at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Alexandria
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Louis M French, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fort Belvoir Community Hospital
name: Heechin Chae, MD
role: PRINCIPAL_INVESTIGATOR
References: