Clinical trial NCT04369911: Acupuncture in Traumatic Brain Injury
Official title: Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post-traumatic Headache
Mild Traumatic Brain Injury
Keywords: acupuncture
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Minnesota Office of Higher Education
First posted: 2020-04-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Number of Headache Days
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 16 weeks
measure: Compliance With Overall Protocol
timeFrame: 3 months
Other outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months
measure: Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)
timeFrame: 3 months
measure: Change in Headache Pain Intensity
timeFrame: baseline to 3 months
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neuroscience Research
name: Amanda A Herrmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: