Acupuncture in Traumatic Brain Injury

NCT04369911 | Completed Results

• 1 other identifier: A19-094
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in Number of Headache Days

  The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.

  baseline to 3 months

Secondary Outcomes (2)

• Adverse Events

  16 weeks

• Compliance With Overall Protocol

  3 months

Other Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI)

  3 months

• Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)

  3 months

• Change in Headache Pain Intensity

  baseline to 3 months

Study Arms (2)

Low Dose

EXPERIMENTAL

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

Procedure: Acupuncture

High Dose

EXPERIMENTAL

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

Procedure: Acupuncture

Interventions

Acupuncture 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; Low Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Minnesota Office of Higher Education: collaborator

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Amanda Herrmann, PhD
• Organization: HealthPartners Institute

amanda.a.herrmann@healthpartners.com

6514956565

Study Officials

• Amanda A Herrmann, PhD

  HealthPartners Neuroscience Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: November 23, 2020
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)