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Recruiting NCT06583122

Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

No phase Interventional Nerve Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Guided Approach.
Who it may be relevant to
Registry conditions: Nerve Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Ultrasound Guided Approach
    All enrolled patients will receive the new ultrasound-guided approach to occipital nerve radiofrequency ablation

Primary outcome measures

  • Reduction pain scores reported using an 11-point numeric rating scale (NRS) [Time frame: 18 Months]
Secondary outcome measures (3)
  • Frequency of headache days [Time frame: 18 months]
  • Frequency of moderate-severe headaches [Time frame: 18 months]
  • Use of acute pain medications [Time frame: 18 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT06583122 · STUDY00148697

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗