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Recruiting

NCT Number: NCT06583122

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Manuel Clark

CONTACT

[email protected]

9139455763

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound Guided Approach

Procedure

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

Primary outcomes

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

    Time frame: 18 Months

    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

Secondary outcomes

  1. Frequency of headache days

    Time frame: 18 months

    We will compare frequency of headache days pre-intervention and post-intervention

  2. Frequency of moderate-severe headaches

    Time frame: 18 months

    We will compare frequency of moderate-severe headaches days pre-intervention and post-intervention

  3. Use of acute pain medications

    Time frame: 18 Months

    We will compare frequency of Use of acute pain medications pre-intervention and post-intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Clark

CONTACT

[email protected]

913-945-5763

Timothy Sowder, MD

CONTACT

[email protected]

913-588-6670

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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