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

Not Applicable

Terminated

• Conditions: Post-Traumatic Headache; Traumatic Brain Injury
• Interventions: Other: Acupuncture

• Registration Number: NCT04216173
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-14
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-02
• Study Start: 2020-02-06
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	-

Primary Outcome Measures

Name	Time	Method
Proportion of weekly acupuncture sessions completed over 12 consecutive weeks	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	12 weeks	Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Data completeness in survey questionnaires	12 weeks	Data completeness in survey questionnaires will be evaluated during data collection.
Participants' perceptions of feasibility of the study with structured interviews	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

Name	Time	Method
Self-reported changes in medication dose	Baseline, 12 weeks	Changes in medication
Headache Impact Test - 6	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)	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	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	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	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	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	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	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	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 Short Form v2.0 - Cognitive Function 4a	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.
PROMIS Pain Intensity Item (Global07)	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.

Trial Locations

Locations (1)

Harborview Injury Prevention and Research Center; 🇺🇸 Seattle, Washington, United States