Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

NCT06583122 | Recruiting

• 1 other identifier: STUDY00148697
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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

  18 Months

Secondary Outcomes (3)

• Frequency of headache days

  18 months

• Frequency of moderate-severe headaches

  18 months

• Use of acute pain medications

  18 Months

Study Arms (1)

Ultrasound Guided Approach

EXPERIMENTAL

Ultrasound-guided approach to occipital nerve radiofrequency ablation

Procedure: Ultrasound Guided Approach

Interventions

Ultrasound Guided Approach PROCEDURE

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

Ultrasound Guided Approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Timothy Sowder, MD

CONTACT

913-588-6670; tsowder@kumc.edu

Manuel Clark

CONTACT

913-945-5763; mclark16@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: July 1, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)