A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury
Sponsor study identifier
interventional
45
1 country
2
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 28, 2011
Actual (reported)April 19, 2011
Actual (reported)April 2015
Actual (reported)April 2015
Actual (reported)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
Daily Headache Diary
Completed daily for 6 weeks
Change from Baseline in Numerical Rating Scale at Week 6
Baseline, Week 6
Change from Baseline in Beck Depression Inventory at Week 6
Baseline, Week 6
Change from Baseline in State-Trait Anxiety Inventory at Week 6
Baseline, Week 6
Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6
Baseline, Week 6
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.
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.
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.
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Fort Belvoir Community Hospital
Alexandria, Virginia, 22060, United States
Louis M French, PsyD
Walter Reed Army Medical Center
Heechin Chae, MD
Fort Belvoir Community Hospital
45 participants (actual enrollment reported by the registry).
First Submitted
March 28, 2011
First Posted
April 19, 2011
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Hypothermia in Traumatic Brain Injury in Children (HiTBIC)
All study participants continue to receive routine usual care for their TBI, headaches and associated symptoms as determined by their clinical team.
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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Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
May 13, 2016
Record last verified: 2016-05
Results will be shared in a published manuscript.
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Source: ClinicalTrials.gov.
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