Status:
RECRUITING
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Nerve Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pa...
Eligibility Criteria
Inclusion
- Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region.
- A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve.
- Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block.
- Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain.
- Failed treatment will be \<50% pain reduction with oral medication.
- Patients must report headache frequency of at least 10 days per month.
Exclusion
- Patients will be excluded from the trial if they have an unstable medical or psychological condition,
- are pregnant,
- have an implanted cardiac pacemaker or defibrillator that could not be disabled,
- have had a craniotomy or scar tissue overlying the site from a previous surgery,
- have a history of cervical spine fusion,
- have evidence of elevated ICP or intracranial tumor,
- or have previous RFA treatment of the greater or lesser occipital nerve.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06583122
Start Date
July 1 2022
End Date
December 31 2026
Last Update
April 9 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160