80 Participants Needed

Radiofrequency Ablation Techniques for Neck Pain

Recruiting at 2 trial locations
SC
TB
PR
Overseen ByPMR Research Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two tools for a heat-based treatment that deactivates pain-causing nerves in the neck. It targets patients with chronic neck pain who have shown significant improvement in preliminary tests. The goal is to see if the newer tool is as effective and safer than the older one.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using daily chronic opiates over 50 morphine equivalents, you may not be eligible to participate.

Is radiofrequency ablation for neck pain safe?

Radiofrequency ablation for neck pain is generally considered safe, but there are risks, such as the potential for spinal cord injury, especially when performed at certain levels like C7. It's important to ensure the procedure is done accurately to minimize these risks.12345

How is the treatment Cervical Medial Branch Radiofrequency Ablation (CMBRFA) unique for neck pain?

Cervical Medial Branch Radiofrequency Ablation (CMBRFA) is unique because it uses radiofrequency energy to target specific nerves in the neck that are responsible for pain, providing a minimally invasive option for patients whose pain does not respond to other treatments. This technique is guided by precise diagnostic blocks to ensure the correct nerves are treated, and a new end-on approach with multi-tined cannulae may offer a simpler and quicker procedure with less discomfort compared to traditional methods.12678

What data supports the effectiveness of the treatment Cervical Medial Branch Radiofrequency Ablation for neck pain?

Research shows that Cervical Medial Branch Radiofrequency Ablation (CMBRFA) is effective for treating neck pain caused by facet joint issues, especially when patients are carefully selected based on specific guidelines. Studies indicate that this treatment can provide significant pain relief for those with chronic neck pain related to cervical facet joint disease.12789

Are You a Good Fit for This Trial?

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 β‰₯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.

Inclusion Criteria

My average neck pain score is 4 or more out of 10.
I have had neck pain for at least 3 months that does not spread to my arms.
The doctor will decide the appropriate tests based on your symptoms, physical exam, and imaging results.
See 6 more

Exclusion Criteria

Those unable to read English and complete the assessment instruments
I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.
You have a pacemaker or neurostimulator.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cervical medial branch radiofrequency ablation using either the Trident or conventional cannula

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain response, functional response, and perception of improvement at 3, 6, and 12 months

12 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cervical Medial Branch Radiofrequency Ablation
Trial Overview 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.
How Is the Trial Designed?
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.

Cervical Medial Branch Radiofrequency Ablation is already approved in United States, Canada, Switzerland for the following indications:

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Approved in United States as Cervical Medial Branch Radiofrequency Ablation for:
  • Cervical facet pain
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Approved in Canada as Cervical Medial Branch Radiofrequency Ablation for:
  • Cervical facet pain
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Approved in Switzerland as Cervical Medial Branch Radiofrequency Ablation for:
  • Cervical facet pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Published Research Related to This Trial

The study analyzed 20 cervical specimens from adult cadavers to clarify the anatomy of cervical medial branches, revealing that while most branches have one medial branch, 27% of C4, 15% of C5, and 2% of C6 branches have two, which is crucial for accurate treatment planning.
The findings provide important anatomical details, such as the average distance of medial branches from the inferior articular process and their location relative to the transverse process, which can enhance the safety and effectiveness of radiofrequency denervation procedures for chronic neck pain.
Anatomical analysis of medial branches of dorsal rami of cervical nerves for radiofrequency thermocoagulation.Kweon, TD., Kim, JY., Lee, HY., et al.[2022]
In a study of 120 patients with chronic neck pain from cervical facet joints, both groups receiving cervical medial branch blocks (with or without steroids) showed significant pain relief, with 85% in the bupivacaine-only group and 93% in the bupivacaine plus steroid group achieving at least 50% pain reduction over 2 years.
The average duration of pain relief from each injection was about 17-19 weeks, and significant improvements in pain and function were maintained for 83 to 89 weeks, indicating that these treatments can provide long-term benefits for managing chronic neck pain.
Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial.Manchikanti, L., Singh, V., Falco, FJ., et al.[2022]
This study will compare a new end-on approach for cervical medial branch nerve radiofrequency neurotomy (RFN) against the conventional parallel technique in 72 adults with chronic neck pain due to cervical facet joint disease, aiming to determine if the new method is equally effective while being technically easier and causing less discomfort.
The trial will assess pain intensity and related factors over 12 months, providing valuable insights into the safety and efficacy of the end-on approach, which could improve treatment options for patients suffering from this common condition.
End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study.Alomari, A., Ferreira-Dos-Santos, G., Singh, M., et al.[2023]

Citations

Anatomical analysis of medial branches of dorsal rami of cervical nerves for radiofrequency thermocoagulation. [2022]
Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. [2022]
End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. [2023]
Long-term follow-up of cervical facet medial branch radiofrequency treatment with the single posterior-lateral approach: an exploratory study. [2014]
The Effectiveness of Cervical Medial Branch Radiofrequency Ablation for Chronic Facet Joint Syndrome in Patients Selected by a Practical Medial Branch Block Paradigm. [2021]
Spinal Cord Injury During Ultrasound-Guided C7 Cervical Medial Branch Block. [2022]
Comparative Outcome of Lidocaine Versus Bupivacaine for Cervical Medial Branch Block in Chronic Cervical Facet Arthropathy: A Randomized Double-Blind Study. [2023]
Single Entry Posterior Parasagittal Approach Radiofrequency Neurotomy of Cervical Medial Branch: A Feasible Alternative to Conventional Approaches in the Treatment of Cervical Facet Pain. [2022]
Cervical Medial Branch Block Volume Dependent Dispersion Patterns as a Predictor for Ablation Success: A Cadaveric Study. [2020]
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