Acupuncture in Traumatic Brain Injury

Not Applicable

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Low Dose	Acupuncture	Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
High Dose	Acupuncture	Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.

Primary Outcome Measures

Name	Time	Method
Change in Number of Headache Days	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

Name	Time	Method
Adverse Events	16 weeks	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.
Compliance With Overall Protocol	3 months	Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.