Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

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 Overview

• Status: Recruiting
• Conditions: Nerve Pain

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Sowder, MD; Phone Number: 913-588-6670; Email: tsowder@kumc.edu
• Study Contact Backup: Name: Manuel Clark; Phone Number: 913-945-5763; Email: mclark16@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of headache days	We will compare frequency of headache days pre-intervention and post-intervention	18 months
Frequency of moderate-severe headaches	We will compare frequency of moderate-severe headaches days pre-intervention and post-intervention	18 months
Use of acute pain medications	We will compare frequency of Use of acute pain medications pre-intervention and post-intervention	18 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: STUDY00148697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No