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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 : Suspended (Temporary suspension of all study activities due to COVID-19.)
First Posted : January 2, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Sodders, University of Washington

Tracking Information
First Submitted Date  ICMJE December 14, 2019
First Posted Date  ICMJE January 2, 2020
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE February 6, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Self-reported changes in medication dose [ Time Frame: Baseline, 12 weeks ]
    Changes in medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
Official Title  ICMJE Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Post-Traumatic Headache
  • Traumatic Brain Injury
Intervention  ICMJE Other: Acupuncture
Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.
Study Arms  ICMJE Experimental: Acupuncture
Intervention: Other: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 31, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04216173
Other Study ID Numbers  ICMJE STUDY00008281
KL2TR002317-03S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Sodders, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark D Sodders, DOAM University of Washington
PRS Account University of Washington
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP