Clinical trial NCT04216173: 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
Overall status: TERMINATED
Phase: NA
Conditions: Post-Traumatic Headache
Traumatic Brain Injury
Keywords: Acupuncture
Post-traumatic headache
Traumatic brain injury
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of weekly acupuncture sessions completed over 12 consecutive weeks
timeFrame: 12 weeks
measure: Proportion of survey questionnaires completed
timeFrame: Baseline
measure: Proportion of survey questionnaires completed
timeFrame: 2 weeks
measure: Proportion of survey questionnaires completed
timeFrame: 4 weeks
measure: Proportion of survey questionnaires completed
timeFrame: 6 weeks
measure: Proportion of survey questionnaires completed
timeFrame: 8 weeks
measure: Proportion of survey questionnaires completed
timeFrame: 10 weeks
measure: Proportion of survey questionnaires completed
timeFrame: 12 weeks
measure: Data completeness in survey questionnaires
timeFrame: Baseline
measure: Data completeness in survey questionnaires
timeFrame: 2 weeks
measure: Data completeness in survey questionnaires
timeFrame: 4 weeks
measure: Data completeness in survey questionnaires
timeFrame: 6 weeks
measure: Data completeness in survey questionnaires
timeFrame: 8 weeks
measure: Data completeness in survey questionnaires
timeFrame: 10 weeks
measure: Data completeness in survey questionnaires
timeFrame: 12 weeks
measure: Participants' perceptions of feasibility of the study with structured interviews
timeFrame: After 12 weeks, or within two weeks of withdrawal from the study
Secondary outcomes:
measure: Headache Impact Test - 6
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v1.0 - Anxiety 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v2.0 - Physical Function 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v1.0 - Pain Interference 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v1.0 - Fatigue 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v1.0 - Sleep Disturbance 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v1.0 - Ability to Participate in Social Roles and Activities 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Pain Intensity Item (Global07)
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: PROMIS Short Form v2.0 - Cognitive Function 4a
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
measure: Self-reported changes in medication dose
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Injury Prevention and Research Center
state: Washington
Study officials:
affiliation: University of Washington
name: Mark D Sodders, DOAM
role: PRINCIPAL_INVESTIGATOR
References: