NCT04216173

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

December 14, 2019

Last Update Submit

September 17, 2021

Conditions

Post-Traumatic HeadacheTraumatic Brain Injury

Keywords

AcupuncturePost-traumatic headacheTraumatic brain injury

Outcome Measures

Primary Outcomes (16)

  • 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.

    12 weeks

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    Baseline

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    2 weeks

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    4 weeks

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    6 weeks

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    8 weeks

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    10 weeks

  • Proportion of survey questionnaires completed

    Respondent burden will be evaluated by the proportion of survey questionnaires completed.

    12 weeks

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    Baseline

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    2 weeks

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    4 weeks

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    6 weeks

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    8 weeks

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    10 weeks

  • Data completeness in survey questionnaires

    Data completeness in survey questionnaires will be evaluated during data collection.

    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.

    After 12 weeks, or within two weeks of withdrawal from the study

Secondary Outcomes (12)

  • Headache Impact Test - 6

    Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • Patient Health Questionnaire-9 (PHQ-9)

    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

    Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • PROMIS Short Form v1.0 - Anxiety 4a

    Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • PROMIS Short Form v2.0 - Physical Function 4a

    Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

  • +7 more secondary outcomes

Study Arms (1)

Acupuncture

EXPERIMENTAL
Other: Acupuncture

Interventions

AcupunctureOTHER

Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.

Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age and older
  • English Speaking
  • Able to provide voluntarily consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Injury Prevention and Research Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Post-Traumatic HeadacheBrain Injuries, Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Mark D Sodders, DOAM

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doctoral Scholar, Principal Investigator

Study Record Dates

First Submitted

December 14, 2019

First Posted

January 2, 2020

Study Start

February 6, 2020

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)