What is the mechanism of action of this treatment?

Cervical Medial Branch Radiofrequency Ablation (CMBRFA) is a common treatment for Cervical Facet Pain, which involves using radiofrequency energy to create heat lesions on the medial branch nerves that innervate the facet joints. The Trident Multi-Tined Cannula, a novel technology, creates a large ablative lesion distal to its triple-tined tip, allowing for a single lesion per medial branch. This method disrupts the pain signals transmitted by the medial branch nerves, providing significant pain relief. The efficiency and safety of this approach, with reduced procedural discomfort, time, and radiation exposure, are particularly beneficial for patients, as it offers a more practical and less invasive option compared to conventional methods requiring multiple lesions.

What side effects are associated with this type of intervention?

Common side effects of treatments for cervical facet pain, such as cervical medial branch radiofrequency ablation (CMBRFA), include temporary local pain at the treatment site, numbness, and muscle weakness. There is also a risk of infection, bleeding, and, in rare cases, nerve damage. The Trident Multi-Tined Cannula, which creates a large ablative lesion with a single lesion per medial branch, aims to improve safety and efficiency, potentially reducing procedural discomfort and radiation exposure.

What prior FDA approvals exist?

The FDA has approved various treatments for cervical facet pain, including devices for cervical medial branch radiofrequency ablation (CMBRFA). Traditional CMBRFA uses a conventional monopolar cannula to create multiple lesions along the medial branch nerve. The Trident Multi-Tined Cannula, which is currently under investigation, aims to improve efficiency and safety by creating a large ablative lesion distal to its triple-tined tip, allowing for a single lesion per medial branch. This approach contrasts with the conventional method that requires multiple burn cycles. While specific FDA approvals for the Trident device are not detailed, the general approval of radiofrequency ablation devices for cervical facet pain management is well-established.

What other types of research exist?

Promising novel alternatives to the Trident Multi-Tined Cannula for cervical facet pain include cooled radiofrequency ablation (CRFA) and pulsed radiofrequency (PRF) ablation. CRFA uses a specialized probe to create larger, more uniform lesions, potentially improving pain relief duration. PRF ablation delivers intermittent bursts of radiofrequency energy, which may reduce pain with less tissue damage compared to continuous RFA. Both methods aim to enhance safety and efficacy in treating cervical facet pain.

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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

Must not have

Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)

Prior cervical medial branch radiofrequency neurotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.

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I have had a neck nerve pain treatment with heat.

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I need sedation through an IV for procedures.

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I do not have an infection in my body at the time of the procedure.

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I do not have any uncontrolled bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

Post Procedure Disability Response

Post Procedure Patient Impression of Change

Procedural Radiation Dose

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cervical Medial Branch Radiofrequency Ablation (CMBRFA) is a common treatment for Cervical Facet Pain, which involves using radiofrequency energy to create heat lesions on the medial branch nerves that innervate the facet joints. The Trident Multi-Tined Cannula, a novel technology, creates a large ablative lesion distal to its triple-tined tip, allowing for a single lesion per medial branch. This method disrupts the pain signals transmitted by the medial branch nerves, providing significant pain relief. The efficiency and safety of this approach, with reduced procedural discomfort, time, and radiation exposure, are particularly beneficial for patients, as it offers a more practical and less invasive option compared to conventional methods requiring multiple lesions.