Post-Traumatic HeadacheNCT04216173
Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
A study testing Acupuncture in people with Post-Traumatic Headache and Traumatic Brain Injury, run by University of Washington at 1 site in United States.
Trial summary
This study evaluates and addresses challenges to implementing an acupuncture intervention for adults who have headaches after sustaining a moderate traumatic brain injury. Eligible participants will be recruited from Seattle and the surrounding areas to receive weekly acupuncture for 12 consecutive weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache, Traumatic Brain Injury
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 12 Mar 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a history of moderate traumatic brain injury (TBI) one to five years previously
- Currently under medical supervision for post-traumatic headache
- Have a score ≥ 3 on the Patient Health Questionnaire 2
- Have a raw summed score ≤ 6 on the PROMIS Cognitive Function Short Form v2.0 - Abilities 2a (part of PROMIS-29+2 Profile)
- Community-dwelling
- 18 years of age and older
- English Speaking
- Able to provide voluntarily consent
Who cannot join
- History of multiple TBIs
- History of receiving acupuncture treatment in the past six months for the primary condition of headache
- An established diagnosis of PTSD
- Psychosis or agitation
- Other neurodegenerative disorders
- Other medical/surgical condition that precludes travel to participate in the intervention over the study duration
Show all 10Show fewer
- Has an active skin lesion or acute trauma over or around the proposed acupuncture points
- History of trauma to the head that currently prevents the use of acupuncture points along the midline of the scalp
- Persons who are pregnant
- Unable to provide informed consent for the research as identified as answering more than two incorrect responses on the Six-item Screener
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Injury Prevention and Research Center
Seattle, Washington, 98104
About this study
This study evaluates and addresses challenges to implementing an acupuncture intervention for adults who have headaches after sustaining a moderate traumatic brain injury. Eligible participants will be recruited from Seattle and the surrounding areas to receive weekly acupuncture for 12 consecutive weeks. Participants will complete questionnaires to assess headache impact, depression, health-related quality of life, and cognitive function at the beginning of the study and every two weeks for the duration of the study. Participants will participate in structured interviews after the study for their views on the acceptability and tolerability of the study protocol.
- Conditions
- Post-Traumatic Headache, Traumatic Brain Injury
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Post-traumatic headache, Traumatic brain injury
- Medical subject headings
- Post-Traumatic Headache, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of weekly acupuncture sessions completed over 12 consecutive weeks
Retention rate will be evaluated by the proportion of weekly acupuncture sessions completed per participant over the course of 12 consecutive weeks.
Measured: 12 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: Baseline
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: 2 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: 4 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: 6 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: 8 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: 10 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Measured: 12 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: Baseline
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: 2 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: 4 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: 6 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: 8 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: 10 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Measured: 12 weeks
Participants' perceptions of feasibility of the study with structured interviews
After 12 weeks in the study, participants will participate in structured interviews for their views on the acceptability and tolerability of the study protocol and acupuncture protocol, recommendations for recruitment and retention, and experiences during the intervention. Interviews with participants withdrawn from the study will be attempted within two weeks of the withdrawal.
Measured: After 12 weeks, or within two weeks of withdrawal from the study
Secondary outcomes (12)
Headache Impact Test - 6
A brief measure describing how a headache affects a participant's functional health and well-being. Score ranges from 36 to 78. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
A measure of depression severity. Scores may range from zero to 27. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Participant reported measure of depression collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Anxiety 4a
Participant reported measure of anxiety, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v2.0 - Physical Function 4a
Participant reported measure of physical function, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Pain Interference 4a
Participant reported measure of pain interference, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Fatigue 4a
Participant reported measure of fatigue, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Participant reported measure of sleep disturbance, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Ability to Participate in Social Roles and Activities 4a
Participant reported measure of one's ability to participate in social roles and other activities, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Pain Intensity Item (Global07)
Participant reported measure of pain intensity, collected as a part of the PROMIS-29 v2.1 profile. This is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v2.0 - Cognitive Function 4a
Participant reported measure of cognitive function. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Self-reported changes in medication dose
Changes in medication
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start6 Feb 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Permanent suspension of all study activities due to COVID-19 and subsequent loss of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Sodders, University of Washington
- Investigators
- Mark D Sodders, DOAM, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216173
- Sponsor's protocol ID
- STUDY00008281
- Other IDs
- KL2TR002317-03S1
- Status last verified
- Sep 2021
- First submitted
- 14 Dec 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04216173
- Acronym / sponsor ID
- STUDY00008281
- Conditions
- Post-Traumatic Headache, Traumatic Brain Injury
- Keywords
- Acupuncture, Post-traumatic headache, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Permanent suspension of all study activities due to COVID-19 and subsequent loss of funding.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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 evaluates and addresses challenges to implementing an acupuncture intervention for adults who have headaches after sustaining a moderate traumatic brain injury. Eligible participants will be recruited from Seattle and the surrounding areas to receive weekly acupuncture for 12 consecutive weeks. Participants will complete questionnaires to assess headache impact, depression, health-related quality of life, and cognitive function at the beginning of the study and every two weeks for the duration of the study. Participants will participate in structured interviews after the study for their views on the acceptability and tolerability of the study protocol.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has a history of moderate traumatic brain injury (TBI) one to five years previously
- Currently under medical supervision for post-traumatic headache
- Have a score ≥ 3 on the Patient Health Questionnaire 2
- Have a raw summed score ≤ 6 on the PROMIS Cognitive Function Short Form v2.0 - Abilities 2a (part of PROMIS-29+2 Profile)
- Community-dwelling
Key exclusion criteria (10 listed)
- History of multiple TBIs
- History of receiving acupuncture treatment in the past six months for the primary condition of headache
- An established diagnosis of PTSD
- Psychosis or agitation
- Other neurodegenerative disorders
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 |
|---|---|---|
| AcupunctureAcupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points. | Other | Acupuncture |
Primary outcome
Proportion of weekly acupuncture sessions completed over 12 consecutive weeks
Time frame: 12 weeks
Retention rate will be evaluated by the proportion of weekly acupuncture sessions completed per participant over the course of 12 consecutive weeks.
Proportion of survey questionnaires completed
Time frame: Baseline
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Time frame: 2 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Time frame: 4 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Time frame: 6 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Time frame: 8 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Time frame: 10 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Time frame: 12 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Data completeness in survey questionnaires
Time frame: Baseline
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Time frame: 2 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Time frame: 4 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Time frame: 6 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Time frame: 8 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Time frame: 10 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Time frame: 12 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Participants' perceptions of feasibility of the study with structured interviews
Time frame: After 12 weeks, or within two weeks of withdrawal from the study
After 12 weeks in the study, participants will participate in structured interviews for their views on the acceptability and tolerability of the study protocol and acupuncture protocol, recommendations for recruitment and retention, and experiences during the intervention. Interviews with participants withdrawn from the study will be attempted within two weeks of the withdrawal.
12 secondary outcomes
Headache Impact Test - 6
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Anxiety 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v2.0 - Physical Function 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Pain Interference 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Fatigue 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Ability to Participate in Social Roles and Activities 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Pain Intensity Item (Global07)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v2.0 - Cognitive Function 4a
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Self-reported changes in medication dose
Time frame: Baseline, 12 weeks
Results and safety
The study was stopped early (reason given: Permanent suspension of all study activities due to COVID-19 and subsequent loss of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Mark D Sodders, DOAM principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Post-Traumatic Headache and Traumatic Brain Injury, run by University of Washington at 1 site 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 10 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: stopped early, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Permanent suspension of all study activities due to COVID-19 and subsequent loss of funding.). Results are not available in the source record.
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?
Proportion of weekly acupuncture sessions completed over 12 consecutive weeks (time frame: 12 weeks). The study lists 16 primary outcomes in all. 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 24 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.