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Completed

NCT Number: NCT01338701

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

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.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Walter Reed Army Medical Center, Washington D.C., District of Columbia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-69 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change from Baseline in Headache Impact Test at Week 6

    Time frame: Baseline, Week 6, Week 12

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

Secondary outcomes

  1. Daily Headache Diary

    Time frame: Completed daily for 6 weeks

    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.

  2. Change from Baseline in Numerical Rating Scale at Week 6

    Time frame: Baseline, Week 6

    This assesess pain along a 0-10 scale. It takes less than a minute to complete.

  3. Change from Baseline in Beck Depression Inventory at Week 6

    Time frame: Baseline, Week 6

    This is a 21-question inventory that rates depressive symptoms. It takes approximately 5 minutes to complete.

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

    Time frame: Baseline, Week 6

    This is a 40-item survey that measures anxiety symptoms. It takes approximately 5 minutes to complete.

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

    Time frame: Baseline, 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.

  6. Change from Baseline in Symptom Checklist 90-R at Week 6

    Time frame: Baseline, 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.

  7. Change from Baseline in Medical Outcome Study Quality of Life at Week 6

    Time frame: Baseline, Week 6

    This measure evaluates physical and psychological functioning. It takes approximately 10 minutes to complete.

  8. Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6

    Time frame: Baseline, Week 6

    This measure evaluates cognitive function and takes approximately 30 minutes to complete.

  9. Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6

    Time frame: Baseline, Week 6

    This measure evaluates sleep quality and disturbances over athe past month. It takes approximately 7 minutes to complete.

  10. Change from Baseline in Expectancy Scale at Week 6

    Time frame: Baseline, Week 6

    This measures participants' pre-conceived expectations about the effect of acupuncture on headaches. It takes less than a minute to complete.

Sponsors and collaborators

Lead sponsor

Samueli Institute for Information Biology

Other

Collaborators

  • Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 19, 2011
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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