Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

University of Kansas Medical Center1 site in 1 country20 target enrollmentJuly 1, 2022

ConditionsNerve Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nerve Pain
Sponsor: University of Kansas Medical Center
Enrollment: 20
Locations: 1
Primary Endpoint: Reduction pain scores reported using an 11-point numeric rating scale (NRS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 pain after the standard of care procedure.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Kansas Medical Center

Responsible Party

Principal Investigator

Timothy Sowder, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Outcomes

Primary Outcomes

Reduction pain scores reported using an 11-point numeric rating scale (NRS)

Time Frame: 18 Months

Pain scores will be assessed 0-10 at the beginning of the study and at the end. We will compare mean pain scores pre-intervention and post-intervention, and we expect mean pain scores will decrease by 4 points on the NRS