Acupuncture in Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

— AccuTBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369911
• Other study ID #: A19-094
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: October 17, 2023

Study information

• Verified date: December 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Post-traumatic Headache
• Headache
• Mild Traumatic Brain Injury
• Post-Traumatic Headache
• Tension-Type Headache
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Minnesota Office of Higher Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	Compliance with overall protocol	Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.	3 months
Secondary	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