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

• Sponsor: University of Washington (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04216173
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Headache; Traumatic Brain Injury	Other: Acupuncture	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
• Actual Study Start Date: Feb 6, 2020
• Actual Primary Completion Date: Mar 12, 2020
• Actual Study Completion Date: Mar 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture	Other: Acupuncture; Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Proportion of survey questionnaires completed [Baseline]

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

3. Proportion of survey questionnaires completed [2 weeks]

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

4. Proportion of survey questionnaires completed [4 weeks]

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

5. Proportion of survey questionnaires completed [6 weeks]

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

6. Proportion of survey questionnaires completed [8 weeks]

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

7. Proportion of survey questionnaires completed [10 weeks]

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

8. Proportion of survey questionnaires completed [12 weeks]

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

9. Data completeness in survey questionnaires [Baseline]

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

10. Data completeness in survey questionnaires [2 weeks]

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

11. Data completeness in survey questionnaires [4 weeks]

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

12. Data completeness in survey questionnaires [6 weeks]

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

13. Data completeness in survey questionnaires [8 weeks]

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

14. Data completeness in survey questionnaires [10 weeks]

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

15. Data completeness in survey questionnaires [12 weeks]

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

16. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. Self-reported changes in medication dose [Baseline, 12 weeks]

    Changes in medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Injury Prevention and Research Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: Mark D Sodders, DOAM, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Sodders, Post Doctoral Scholar, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT04216173
• Other Study ID Numbers: STUDY00008281; KL2TR002317-03S1
• First Posted: Jan 2, 2020
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mark Sodders, Post Doctoral Scholar, Principal Investigator, University of Washington: Acupuncture; Post-traumatic headache; Traumatic brain injury
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Traumatic Headache; Headache; Wounds and Injuries

Study Results

No Results Posted as of Sep 24, 2021