Status:
COMPLETED
Acupuncture in Traumatic Brain Injury
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Minnesota Office of Higher Education
Conditions:
Chronic Post-traumatic Headache
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04369911
Start Date
November 23 2020
End Date
October 17 2023
Last Update
January 27 2025
Active Locations (1)
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1
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States, 55130