Recruiting

Radiofrequency Ablation

Sponsor:

University of Kansas Medical Center

Code:

NCT06583122

Conditions

Nerve Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound Guided Approach

Study Details

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.

Conditions

Nerve Pain

Study ID

NCT06583122

Start date

Jul 1, 2022

Status verified date

Dec, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ultrasound Guided Approach

Ultrasound-guided approach to occipital nerve radiofrequency ablation

Interventions

Ultrasound Guided Approach

All enrolled patients will receive the new ultrasound-guided approach to occipital nerve radiofrequency ablation

Primary outcome measure

  • Reduction pain scores reported using an 11-point numeric rating scale (NRS) [ Time Frame: 18 Months ]

Central Contacts and Locations

Central contacts

Timothy Sowder, MD

913-588-6670tsowder@kumc.edu

Manuel Clark

913-945-5763mclark16@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Manuel Clark

9139455763mclark16@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Apr 9, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-04-09.