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An Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Samueli Institute for Information Biology
Sponsor:
Collaborators:
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT01338701
First received: March 28, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Headache
Traumatic Brain Injury
Procedure: Traditional Chinese Acupuncture
Procedure: Auricular (Ear) Acupuncture
Other: Usual Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Samueli Institute for Information Biology:

Primary Outcome Measures:
  • Change from Baseline in Headache Impact Test at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This is a 6-item measure that assesses headache severity. This will take approximately 1 minute to complete.

  • Change from Week 6 in Headache Impact Test at Week 12 [ Time Frame: Week 6, Week 12 ] [ Designated as safety issue: No ]
    This is a 6-item measure that assesses headache severity. This will take approximately 1 minute to complete.


Secondary Outcome Measures:
  • Daily Headache Diary [ Time Frame: Completed daily for 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in Numerical Rating Scale at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This asseses pain along a 0-10 scale. It takes less than a minute to complete.

  • Change from Baseline in Beck Depression Inventory at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This is a 21-question inventory that rates depressive symptoms. It takes approximately 5 minutes to complete.

  • Change from Baseline in State-Trait Anxiety Inventory at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This is a 40-item survey that measures anxiety symptoms. It takes approximately 5 minutes to complete.

  • Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in Symptom Checklist 90-R at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This is a 90-item checklist that evaluates a broad range of symptoms and psychological symptoms. It takes approximately 15 minutes to complete.

  • Change from Baseline in Medical Outcome Study Quality of Life at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This measure evaluates physical and psychological functioning. It takes approximately 10 minutes to complete.

  • Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This measure evaluates cognitive function and takes approximately 30 minutes to complete.

  • Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This measure evaluates sleep quality and disturbances over athe past month. It takes approximately 7 minutes to complete.

  • Change from Baseline in Expectancy Scale at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    This measures participants' pre-conceived expectations about the effect of acupuncture on headaches. It takes less than a minute to complete.


Estimated Enrollment: 90
Study Start Date: February 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Auricular (Ear) Acupuncture 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.
Active Comparator: Traditional Chinese Acupuncture (TCA) Procedure: Traditional Chinese Acupuncture
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 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.

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338701

Contacts
Contact: Courtney Lee, MA 703-299-4817 clee@siib.org
Contact: Jennifer Smith, MPH 703-299-4824 jsmith2@siib.org

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20307
Sponsors and Collaborators
Samueli Institute for Information Biology
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Louis M French, PsyD Walter Reed Army Medical Center
  More Information

No publications provided

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT01338701     History of Changes
Other Study ID Numbers: NCT000820212
Study First Received: March 28, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Samueli Institute for Information Biology:
TBI
Headaches
Military
Acupuncture
Walter Reed Army Medical Center

Additional relevant MeSH terms:
Headache
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014