Acupuncture in Traumatic Brain Injury (AccuTBI)

Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury; Chronic Post-traumatic Headache
• Intervention / Treatment: Procedure: Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose; Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.	Procedure: 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.
Experimental: High Dose; Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The total number of adverse events (AE) or serious adverse events (SAE) over the course of the study. A higher number of AE/SAEs indicates a less safe treatment.	2 years
Compliance with overall protocol	Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.	3 months
Compliance with treatment protocol	Completion of treatment duration. Proportion of participants completed the full 30 minutes treatment session. Range: 0-1. A higher proportion indicates more compliance.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality	3 months
Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)	The TBI-QOL-Headache contains questions about participant's headache pain. Range: 10-50. Raw score converted to T-score. Higher score indicates more headache pain.	3 months
Change in Headache Duration	The headache duration, measured in minutes for each headache day. Days will be totaled for the 4 week period measured. Higher number of headache minutes indicates worse headache control.	baseline to 3 months
Change in Headache Pain Intensity	The headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Pain intensity scale range is 0 (no pain) to 10 (worst pain imaginable). Higher pain intensity score indicates more intense headaches.	baseline to 3 months

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Minnesota Office of Higher Education
• Investigators: Principal Investigator: Amanda A Herrmann, PhD, HealthPartners Neuroscience Research

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: acupuncture
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders, Primary; Headache Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Headache; Tension-Type Headache; Brain Concussion; Post-Traumatic Headache
• Other Study ID Numbers: A19-094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No