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| Name | Class |
|---|---|
| Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury | FED |
| U.S. Army Medical Research and Development Command | FED |
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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.
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:
Subjects in the usual care group will:
All subjects will also:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular (Ear) Acupuncture | Experimental | 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. |
|
| Traditional Chinese Acupuncture (TCA) | Experimental | 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. |
|
| Usual Care | Other | All study participants continue to receive routine usual care for their TBI, headaches and associated symptoms as determined by their clinical team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Louis M French, PsyD | Walter Reed Army Medical Center | Principal Investigator |
| Heechin Chae, MD | Fort Belvoir Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States | ||
| Fort Belvoir Community Hospital |
Results will be shared in a published manuscript.
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|
| 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. |
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| 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. |
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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 |
| Alexandria |
| Virginia |
| 22060 |
| United States |
| ID | Term |
|---|---|
| D006261 | Headache |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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