Acupuncture in Traumatic Brain Injury

NCT ID: NCT04369911

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2023-10-17

Brief Summary

The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people with mild traumatic brain injury (mTBI) suffering from CPTH will be enrolled in this study to receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups: 1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is hypothesized that both treatment groups will have decreased headaches, but that 10 treatments will greater alleviate headaches when compared to 5 treatments.

Conditions

Chronic Post-traumatic Headache; Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Dose

Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

High Dose

Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

Interventions

Acupuncture

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ability to provide and provision of signed and dated informed consent form
• Age 18-65
• Diagnosis of mild traumatic brain injury (mTBI) (as defined by the International classification of headache disorders 3rd edition (ICHD-3); a. Either no loss of consciousness, or loss of consciousness of <30 minutes duration, b. Glascow Coma Scale (GCS) ≥ 13, and c. Symptoms and/or signs diagnostic of concussion)
• Diagnosis of mTBI ≥3 months and ≤12 months at the time of study enrollment
• Suffering from chronic post-traumatic headache (CPTH) of any etiology (e.g. tension or migraine), with chronic defined as developed within 7 days after injury and lasting ≥3 months from the time of injury
• Stable medication regimen for ≥1 months and agree to adhere to his or her current medication treatment regimen through study participation

Exclusion Criteria

• Non-English speaking
• History of acupuncture since diagnosis of mTBI
• History of pre-existing primary headache, defined as more than 12 days of tension-type headache annually and/or more than one migraine attacks per month in the last year
• History of any other serious neurological, psychiatric, chronic pain disorders, or seizures
• History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture
• History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device
• Recent or active substance use disorder
• Women who are currently pregnant, lactating, or planning to become pregnant during the study
• Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)
• Active participation or past participation ≤3 months in any other interventional study.
• Unwilling to participate in all study related activities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minnesota Office of Higher Education

OTHER_GOV

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda A Herrmann, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neuroscience Research

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A19-094

Identifier Type: -

Identifier Source: org_study_id