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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
2
Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.
Harborview Injury Prevention and Research Center
Seattle, Washington, United States
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.
Time frame: 12 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: Baseline
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: 2 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: 4 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: 6 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: 8 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: 10 weeks
Proportion of survey questionnaires completed
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Time frame: 12 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: Baseline
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: 2 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: 4 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: 6 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: 8 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: 10 weeks
Data completeness in survey questionnaires
Data completeness in survey questionnaires will be evaluated during data collection.
Time frame: 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.
Time frame: After 12 weeks, or within two weeks of withdrawal from the study
Headache Impact Test - 6
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
A measure of depression severity. Scores may range from zero to 27. Higher scores indicate worse outcomes.
Time frame: 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
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Anxiety 4a
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v2.0 - Physical Function 4a
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Pain Interference 4a
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
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PROMIS Short Form v1.0 - Fatigue 4a
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Sleep Disturbance 4a
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v1.0 - Ability to Participate in Social Roles and Activities 4a
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Pain Intensity Item (Global07)
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
PROMIS Short Form v2.0 - Cognitive Function 4a
Participant reported measure of cognitive function. There are four questions, with a possible score of four to 20. Lower scores indicate worse outcomes.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Self-reported changes in medication dose
Changes in medication
Time frame: Baseline, 12 weeks