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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States
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.
Time frame: baseline to 3 months
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.
Time frame: 16 weeks
Compliance With Overall Protocol
Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.
Time frame: 3 months
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