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

NCT ID: NCT04216173

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2020-03-12

Brief Summary

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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

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Conditions

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Post-Traumatic Headache Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

Interventions

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Acupuncture

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Mark Sodders

Post Doctoral Scholar, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark D Sodders, DOAM

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Injury Prevention and Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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KL2TR002317-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008281

Identifier Type: -

Identifier Source: org_study_id

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