Acupuncture in Traumatic Brain Injury (AccuTBI)

• ClinicalTrials.gov Identifier: NCT04369911
• Recruitment Status: Active, not recruiting
• First Posted: April 30, 2020
• Last Update Posted: September 14, 2023
• Sponsor: HealthPartners Institute
• Collaborator: Minnesota Office of Higher Education
• Information provided by (Responsible Party): HealthPartners Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Post-traumatic Headache; Mild Traumatic Brain Injury	Procedure: Acupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury
• Actual Study Start Date: November 23, 2020
• Estimated Primary Completion Date: November 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in number of headache days [ Time Frame: baseline to 3 months ]
   The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: 2 years ]
   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. Compliance with overall protocol [ Time Frame: 3 months ]
   Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.
3. Compliance with treatment protocol [ Time Frame: 3 months ]
   Completion of treatment duration. Proportion of participants completed the full 30 minutes treatment session. Range: 0-1. A higher proportion indicates more compliance.

Other Outcome Measures:

1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months ]
   The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality
2. Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) [ Time Frame: 3 months ]
   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. Change in Headache Duration [ Time Frame: baseline to 3 months ]
   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.
4. Change in Headache Pain Intensity [ Time Frame: baseline to 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States, 55130

Sponsors and Collaborators

HealthPartners Institute

Minnesota Office of Higher Education

Investigators

• Principal Investigator: Amanda A Herrmann, PhD; HealthPartners Neuroscience Research

More Information

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT04369911
• Other Study ID Numbers: A19-094
• First Posted: April 30, 2020
• Last Update Posted: September 14, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• 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 HealthPartners Institute:

acupuncture

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Traumatic Headache; Tension-Type Headache; Headache; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pain; Neurologic Manifestations; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache Disorders; Headache Disorders, Primary