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

September 17, 2021 updated by: Mark Sodders, University of Washington
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Injury Prevention and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acupuncture
Other: Acupuncture
Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Proportion of survey questionnaires completed
Time Frame: Baseline
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Baseline
Proportion of survey questionnaires completed
Time Frame: 2 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
2 weeks
Proportion of survey questionnaires completed
Time Frame: 4 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
4 weeks
Proportion of survey questionnaires completed
Time Frame: 6 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
6 weeks
Proportion of survey questionnaires completed
Time Frame: 8 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
8 weeks
Proportion of survey questionnaires completed
Time Frame: 10 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
10 weeks
Proportion of survey questionnaires completed
Time Frame: 12 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
12 weeks
Data completeness in survey questionnaires
Time Frame: Baseline
Data completeness in survey questionnaires will be evaluated during data collection.
Baseline
Data completeness in survey questionnaires
Time Frame: 2 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
2 weeks
Data completeness in survey questionnaires
Time Frame: 4 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
4 weeks
Data completeness in survey questionnaires
Time Frame: 6 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
6 weeks
Data completeness in survey questionnaires
Time Frame: 8 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
8 weeks
Data completeness in survey questionnaires
Time Frame: 10 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
10 weeks
Data completeness in survey questionnaires
Time Frame: 12 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
12 weeks
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.
After 12 weeks, or within two weeks of withdrawal from the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Impact Test - 6
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
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.
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
A measure of depression severity. Scores may range from zero to 27. Higher scores indicate worse outcomes.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Participant reported measure of cognitive function. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Self-reported changes in medication dose
Time Frame: Baseline, 12 weeks
Changes in medication
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Mark D Sodders, DOAM, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2020

Primary Completion (ACTUAL)

March 12, 2020

Study Completion (ACTUAL)

March 12, 2020

Study Registration Dates

First Submitted

December 14, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (ACTUAL)

January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008281
  • KL2TR002317-03S1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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