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Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study

Primary Purpose

Post-Traumatic Headache, Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Traumatic Headache focused on measuring Acupuncture, Post-traumatic headache, Traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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

Sites / Locations

  • Harborview Injury Prevention and Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

Outcomes

Primary Outcome Measures

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.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
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.

Secondary Outcome Measures

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.
Patient Health Questionnaire-9 (PHQ-9)
A measure of depression severity. Scores may range from zero to 27. Higher scores indicate worse outcomes.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Self-reported changes in medication dose
Changes in medication

Full Information

First Posted
December 14, 2019
Last Updated
September 17, 2021
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT04216173
Brief Title
Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
Official Title
Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Permanent suspension of all study activities due to COVID-19 and subsequent loss of funding.
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache, Traumatic Brain Injury
Keywords
Acupuncture, Post-traumatic headache, Traumatic brain injury

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.
Primary Outcome Measure Information:
Title
Proportion of weekly acupuncture sessions completed over 12 consecutive weeks
Description
Retention rate will be evaluated by the proportion of weekly acupuncture sessions completed per participant over the course of 12 consecutive weeks.
Time Frame
12 weeks
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
Baseline
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
2 weeks
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
4 weeks
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
6 weeks
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
8 weeks
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
10 weeks
Title
Proportion of survey questionnaires completed
Description
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time Frame
12 weeks
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
Baseline
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
2 weeks
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
4 weeks
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
6 weeks
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
8 weeks
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
10 weeks
Title
Data completeness in survey questionnaires
Description
Data completeness in survey questionnaires will be evaluated during data collection.
Time Frame
12 weeks
Title
Participants' perceptions of feasibility of the study with structured interviews
Description
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.
Time Frame
After 12 weeks, or within two weeks of withdrawal from the study
Secondary Outcome Measure Information:
Title
Headache Impact Test - 6
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
A measure of depression severity. Scores may range from zero to 27. Higher scores indicate worse outcomes.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v1.0 - Anxiety 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v2.0 - Physical Function 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v1.0 - Pain Interference 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v1.0 - Fatigue 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v1.0 - Ability to Participate in Social Roles and Activities 4a
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Pain Intensity Item (Global07)
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
PROMIS Short Form v2.0 - Cognitive Function 4a
Description
Participant reported measure of cognitive function. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Title
Self-reported changes in medication dose
Description
Changes in medication
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Sodders, DOAM
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Injury Prevention and Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study

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