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Procedure

Radiofrequency Ablation Techniques for Neck Pain

N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patient aged ≥18 capable of understanding and providing consent in English and capable of complying with the outcome instruments used
7-day average numeric pain rating score (NRS) for neck pain of 4/10 or greater at baseline evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months
Awards & highlights

Study Summary

This trial is comparing the effectiveness of two different types of radiofrequency ablation (RFA) for treating cervical facet pain. The first type is the conventional RFA, which has been studied and shown to be effective in the past. The second type is a newer RFA called Trident, which is designed to be more efficient and safe while still maintaining a large ablative lesion. The trial will compare the two types of RFA in terms of pain relief, functionality, and patient perception of improvement.

Who is the study for?
This trial is for adults over 18 with neck pain lasting at least 3 months, who can understand and consent in English. They must have a pain score of at least 4/10 and have shown ≥80% symptom reduction after dual medial branch blocks. Excluded are those with conflicts like litigation or disability claims, allergies to certain medications, chronic widespread pain disorders, prior similar treatments, severe depression or psychosis, possible pregnancy, high daily opiate use, pacemakers or infections.Check my eligibility
What is being tested?
The study compares the Trident multi-tined cannula (a new tool that requires fewer lesions) to the conventional cannula used in cervical medial branch radiofrequency ablation for neck pain relief. It aims to see if Trident is just as effective while reducing procedure discomfort and time as well as radiation exposure.See study design
What are the potential side effects?
Potential side effects may include temporary increase in neck pain following the procedure, minor bleeding or bruising at the site of needle insertion, rare instances of nerve damage leading to increased pain or numbness and infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older, understand English, and can follow the study's procedures.
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My average neck pain score is 4 or more out of 10.
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I have had neck pain for at least 3 months that does not spread to my arms.
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My procedure will follow Spine Intervention Society guidelines.
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I am keeping a pain diary to track how much relief I get.
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I have had neck pain for at least 3 months that does not spread to my arms.
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I responded well to two separate nerve block tests with lidocaine and bupivacaine.
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My pain relief from lidocaine lasts at least 1 hour and from bupivacaine at least 2 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Secondary outcome measures
Post Procedure Disability Response
Post Procedure Patient Impression of Change
Procedural Radiation Dose
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Trident Cervical Medial Branch Radiofrequency AblationActive Control1 Intervention
During this procedure a 50 mm or 100 mm long (dependent on body habitus), 18-gauge insulated cannula with a 5 mm active tip will be placed perpendicularly at targeted medial branches (the nerves carrying pain signals from the facet joints).
Group II: Conventional Cervical Medial Branch Radiofrequency AblationActive Control1 Intervention
During this procedure a 50 mm or 100 mm long (dependent on body habitus), 18-gauge conventional cannula with a straight 5 mm active tip will be placed parallel and oblique to the targeted medial branch branches (the nerves carrying pain signals from the facet joints). At each location, one lesion will be made to accommodate anatomic variation.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,092 Previous Clinical Trials
1,732,912 Total Patients Enrolled

Media Library

Cervical Medial Branch Radiofrequency Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05424198 — N/A
Cervical Facet Pain Research Study Groups: Trident Cervical Medial Branch Radiofrequency Ablation, Conventional Cervical Medial Branch Radiofrequency Ablation
Cervical Facet Pain Clinical Trial 2023: Cervical Medial Branch Radiofrequency Ablation Highlights & Side Effects. Trial Name: NCT05424198 — N/A
Cervical Medial Branch Radiofrequency Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424198 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment currently offer participation opportunities to individuals?

"Affirmative. Clinicaltrials.gov attests that this research study, which was first advertised on April 28th 2022, is presently recruiting participants. Approximately 80 volunteers are necessary to be enrolled from 3 distinct medical locations."

Answered by AI

What are the core objectives of this research trial?

"This clinical trial's primary focus is to evaluate the efficacy of Pain response across a 3, 6 and 12 month period. Secondary assessments include Procedural Radiation Dose (various radiation levels during T-CMBRFA versus C-CMBRFA.), Procedure time comparisons between different treatments, and Post Procedure Patient Impression of Change as measured via Patient Global Impression of Change scores."

Answered by AI

How many participants are there in the current experiment?

"Correct. According to the information available at clinicaltrials.gov, this medical trial is actively looking for candidates and was initially posted on April 28th 2022. 80 patients need to be recruited from 3 separate sites."

Answered by AI

Who else is applying?

What site did they apply to?
University of Utah Farmington Health Center
University of Utah South Jordan Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I've had this pain for over a year and at one point I was not able to hold my head up for an eight hour work day without being in excruciating pain. It hurt to lay my head and neck on a pillow, I couldn't have any angle to it. I had to not work for about 4 months. I have had no injuries to my neck. I had a hard time getting help from a doctor and with the opiod crisis I couldn't get any relief. After 3 1/2 months finally had a MRI and there are bone spurs, stenosis, spondylosis, and I'm not sure what else. I always have pain and I worry about it happening again to the extreme of not working and not getting much help for it. I have to work, I'm single and I have to support myself.
PatientReceived 2+ prior treatments
~43 spots leftby May 2025