Health TrialsbyHealthPanel

Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

ConditionNerve Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Kansas Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • Ultrasound Guided Approach

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Ultrasound Guided ApproachExperimental treatment 1 intervention

Trial outcomes

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

Time frame
18 Months

Secondary outcomes

1

Frequency of headache days

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

Time frame
18 months
2

Frequency of moderate-severe headaches

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

Time frame
18 months
3

Use of acute pain medications

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

Time frame
18 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kansas Medical Center

Lead sponsor

Source ClinicalTrials.gov
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