Back to resultsExploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI
Primary Purpose
Headache, Traumatic Brain Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Traditional Chinese Acupuncture (TCA)
Auricular (Ear) Acupuncture
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring TBI, Headaches, Military, Acupuncture, Walter Reed Army Medical Center, Fort Belvoir Community Hospital
Eligibility Criteria
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
Sites / Locations
- Walter Reed Army Medical Center
- Fort Belvoir Community Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Auricular (Ear) Acupuncture
Traditional Chinese Acupuncture (TCA)
Usual Care
Arm Description
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.
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.
All study participants continue to receive routine usual care for their TBI, headaches and associated symptoms as determined by their clinical team.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6
This measure evaluates cognitive function and takes approximately 30 minutes to complete.
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.
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.
Full Information
NCT ID
NCT01338701
First Posted
March 28, 2011
Last Updated
May 11, 2016
Sponsor
Samueli Institute for Information Biology
Collaborators
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01338701
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samueli Institute for Information Biology
Collaborators
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Traumatic Brain Injury
Keywords
TBI, Headaches, Military, Acupuncture, Walter Reed Army Medical Center, Fort Belvoir Community Hospital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular (Ear) Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Chinese Acupuncture (TCA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
All study participants continue to receive routine usual care for their TBI, headaches and associated symptoms as determined by their clinical team.
Intervention Type
Procedure
Intervention Name(s)
Traditional Chinese Acupuncture (TCA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Auricular (Ear) Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in Headache Impact Test at Week 6
Description
This is a 6-item measure that assesses headache severity. This will take approximately 1 minute to complete.
Time Frame
Baseline, Week 6, Week 12
Secondary Outcome Measure Information:
Title
Daily Headache Diary
Description
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.
Time Frame
Completed daily for 6 weeks
Title
Change from Baseline in Numerical Rating Scale at Week 6
Description
This assesess pain along a 0-10 scale. It takes less than a minute to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Beck Depression Inventory at Week 6
Description
This is a 21-question inventory that rates depressive symptoms. It takes approximately 5 minutes to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in State-Trait Anxiety Inventory at Week 6
Description
This is a 40-item survey that measures anxiety symptoms. It takes approximately 5 minutes to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Symptom Checklist 90-R at Week 6
Description
This is a 90-item checklist that evaluates a broad range of symptoms and psychological symptoms. It takes approximately 15 minutes to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Medical Outcome Study Quality of Life at Week 6
Description
This measure evaluates physical and psychological functioning. It takes approximately 10 minutes to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6
Description
This measure evaluates cognitive function and takes approximately 30 minutes to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6
Description
This measure evaluates sleep quality and disturbances over athe past month. It takes approximately 7 minutes to complete.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Expectancy Scale at Week 6
Description
This measures participants' pre-conceived expectations about the effect of acupuncture on headaches. It takes less than a minute to complete.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis M French, PsyD
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heechin Chae, MD
Organizational Affiliation
Fort Belvoir Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be shared in a published manuscript.
Learn more about this trial
Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI
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