Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

NCT ID: NCT06583122

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound Guided Approach

Ultrasound-guided approach to occipital nerve radiofrequency ablation

Group Type: EXPERIMENTAL

Ultrasound Guided Approach

Intervention Type: PROCEDURE

All enrolled patients will receive the new 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Timothy Sowder, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy Sowder, MD

Role: CONTACT

tsowder@kumc.edu

913-588-6670

Manuel Clark

Role: CONTACT

mclark16@kumc.edu

913-945-5763

Facility Contacts

Manuel Clark

Role: primary

mclark16@kumc.edu

9139455763

Other Identifiers

STUDY00148697

Identifier Type: -

Identifier Source: org_study_id