Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216173
Recruitment Status : Terminated (Permanent suspension of all study activities due to COVID-19 and subsequent loss of funding.)
First Posted : January 2, 2020
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Sodders, University of Washington

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Traumatic Brain Injury Other: Acupuncture Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
Actual Study Start Date : February 6, 2020
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : March 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture Other: Acupuncture
Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.




Primary Outcome Measures :
  1. 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.

  2. Proportion of survey questionnaires completed [ Time Frame: Baseline ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  3. Proportion of survey questionnaires completed [ Time Frame: 2 weeks ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  4. Proportion of survey questionnaires completed [ Time Frame: 4 weeks ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  5. Proportion of survey questionnaires completed [ Time Frame: 6 weeks ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  6. Proportion of survey questionnaires completed [ Time Frame: 8 weeks ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  7. Proportion of survey questionnaires completed [ Time Frame: 10 weeks ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  8. Proportion of survey questionnaires completed [ Time Frame: 12 weeks ]
    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

  9. Data completeness in survey questionnaires [ Time Frame: Baseline ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  10. Data completeness in survey questionnaires [ Time Frame: 2 weeks ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  11. Data completeness in survey questionnaires [ Time Frame: 4 weeks ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  12. Data completeness in survey questionnaires [ Time Frame: 6 weeks ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  13. Data completeness in survey questionnaires [ Time Frame: 8 weeks ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  14. Data completeness in survey questionnaires [ Time Frame: 10 weeks ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  15. Data completeness in survey questionnaires [ Time Frame: 12 weeks ]
    Data completeness in survey questionnaires will be evaluated during data collection.

  16. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Self-reported changes in medication dose [ Time Frame: Baseline, 12 weeks ]
    Changes in medication



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216173


Locations
Layout table for location information
United States, Washington
Harborview Injury Prevention and Research Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Mark D Sodders, DOAM University of Washington
Layout table for additonal information
Responsible Party: Mark Sodders, Post Doctoral Scholar, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT04216173    
Other Study ID Numbers: STUDY00008281
KL2TR002317-03S1 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Sodders, University of Washington:
Acupuncture
Post-traumatic headache
Traumatic brain injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Post-Traumatic Headache
Headache
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders