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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ultrasound Guided Approach 		Ultrasound-guided approach to occipital nerve radiofrequency ablation
  • Procedure: Ultrasound Guided Approach
    All enrolled patients will receive the new ultrasound-guided approach to occipital nerve radiofrequency ablation

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Manuel Clark
9139455763
mclark16@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Timothy Sowder, MD
913-588-6670
tsowder@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.