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Clinical Trials/NCT06583122
NCT06583122RecruitingNot Applicable

Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

University of Kansas Medical Center1 site in 1 country20 target enrollmentStarted: July 1, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Reduction pain scores reported using an 11-point numeric rating scale (NRS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

Ultrasound Guided Approach

Experimental

Ultrasound-guided approach to occipital nerve radiofrequency ablation

Intervention: Ultrasound Guided Approach (Procedure)

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

Secondary Outcomes

  • Frequency of headache days(18 months)
  • Frequency of moderate-severe headaches(18 months)
  • Use of acute pain medications(18 Months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Timothy Sowder, MD

Principal Investigator

University of Kansas Medical Center

Study Sites (1)

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