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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04216173
• Other study ID #: STUDY00008281
• Secondary ID: KL2TR002317-03S1
• Status: Terminated
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: March 12, 2020

Study information

• Verified date: September 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• Post-Traumatic Headache
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Harborview Injury Prevention and Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	Baseline
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	2 weeks
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	4 weeks
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	6 weeks
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	8 weeks
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	10 weeks
Primary	Proportion of survey questionnaires completed	Respondent burden will be evaluated by the proportion of survey questionnaires completed.	12 weeks
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	Baseline
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	2 weeks
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	4 weeks
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	6 weeks
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	8 weeks
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	10 weeks
Primary	Data completeness in survey questionnaires	Data completeness in survey questionnaires will be evaluated during data collection.	12 weeks
Primary	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	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9)	A measure of depression severity. Scores may range from zero to 27. Higher scores indicate worse outcomes.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks
Secondary	Self-reported changes in medication dose	Changes in medication	Baseline, 12 weeks