HeadachePhase 2/3NCT01338701
Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI
A Phase 2/3 study testing Traditional Chinese Acupuncture (TCA) and Auricular (Ear) Acupuncture in people with Headache and Traumatic Brain Injury, run by Samueli Institute for Information Biology at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Traumatic Brain Injury
- What is being tested?
- Traditional Chinese Acupuncture (TCA) and Auricular (Ear) Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Apr 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fort Belvoir Community Hospital
Alexandria, Virginia, 22060
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury
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.
Read the 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
- Conditions
- Headache, Traumatic Brain Injury
- Being tested
- Traditional Chinese Acupuncture (TCA), Auricular (Ear) Acupuncture, Usual Care
- Keywords
- TBI, Headaches, Military, Acupuncture, Walter Reed Army Medical Center, Fort Belvoir Community Hospital
- Medical subject headings
- Headache, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Acupuncture (TCA)Procedure or surgery
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) AcupunctureProcedure or surgery
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Auricular (Ear) Acupuncture |
| 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. Receives: Procedure: Traditional Chinese Acupuncture (TCA) |
| 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, Week 12
Secondary outcomes (10)
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.
Measured: Completed daily for 6 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Louis M French, PsyD, Principal investigator, Walter Reed Army Medical CenterHeechin Chae, MD, Principal investigator, Fort Belvoir Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338701
- Sponsor's protocol ID
- 350890
- Status last verified
- May 2016
- First submitted
- 28 Mar 2011
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results will be shared in a published manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01338701
- Acronym / sponsor ID
- 350890
- Conditions
- Headache, Traumatic Brain Injury
- Keywords
- TBI, Headaches, Military, Acupuncture, Walter Reed Army Medical Center, Fort Belvoir Community Hospital
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, U.S. Army Medical Research and Development Command
- Study start
- Feb 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auricular (Ear) Acupuncture | Experimental | Procedure: Auricular (Ear) AcupunctureAuricular (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 | Procedure: Traditional Chinese Acupuncture (TCA)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 | Other: Usual CareAll study participants continue to receive routine usual care for their TBI, headaches and associated symptoms as determined by their clinical team. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Acupuncture (TCA)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. | Procedure or surgery | Traditional Chinese Acupuncture (TCA) |
| Auricular (Ear) AcupunctureAn 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. | Procedure or surgery | Auricular (Ear) Acupuncture |
| Usual CareSubjects 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. | Other | Usual Care |
Primary outcome
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.
10 secondary outcomes
Daily Headache Diary
Time frame: Completed daily for 6 weeks
Change from Baseline in Numerical Rating Scale at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Beck Depression Inventory at Week 6
Time frame: Baseline, Week 6
Change from Baseline in State-Trait Anxiety Inventory at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Symptom Checklist 90-R at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Medical Outcome Study Quality of Life at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6
Time frame: Baseline, Week 6
Change from Baseline in Expectancy Scale at Week 6
Time frame: Baseline, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Yes. Results will be shared in a published manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis M French, PsyD principal investigator
Walter Reed Army Medical Center
Heechin Chae, MD principal investigator
Fort Belvoir Community Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Traditional Chinese Acupuncture (TCA) and Auricular (Ear) Acupuncture in people with Headache and Traumatic Brain Injury, run by Samueli Institute for Information Biology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Headache Impact Test at Week 6 (time frame: Baseline, Week 6, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.