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Procedure

Ultrasound-Guided Ablation for Neuropathic Pain

N/A
Recruiting
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new method to use ultrasound to guide the treatment of occipital nerve pain. The goal is to reduce pain levels after the procedure compared to the current standard care method.

Who is the study for?
This trial is for adults aged 18-80 with occipital neuralgia or migraines in the occipital region, experiencing headaches at least 10 days a month. They must have tried and not responded well to NSAIDs, opioids, and anticonvulsants. Diagnosis should meet ICHD criteria including specific pain patterns and temporary relief from local anesthetic blocks.
What is being tested?
The study tests an ultrasound-guided method for radiofrequency ablation on the occipital nerve, aiming to visualize the needle during treatment to potentially reduce post-procedure pain compared to standard care.
What are the potential side effects?
While not explicitly listed here, side effects may include discomfort or bruising at the needle insertion site, temporary numbness or weakness due to nerve irritation, and less commonly infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old with occipital neuralgia or migraines in the back of my head.
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I have been diagnosed with occipital neuralgia as per ICHD guidelines.
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I have tried and found no relief from pain with NSAIDs, opioids, and anticonvulsants.
Select...
My pain did not reduce by half even after taking oral medication.
Select...
I experience headaches on 10 or more days each month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction pain scores reported using an 11-point numeric rating scale (NRS)
Secondary study objectives
Frequency of headache days
Frequency of moderate-severe headaches
Use of acute pain medications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ultrasound Guided ApproachExperimental Treatment1 Intervention
Ultrasound-guided approach to occipital nerve radiofrequency ablation

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,879 Total Patients Enrolled
~1 spots leftby Dec 2024
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