What side effects are associated with this type of intervention?

Common treatments for neck pain, such as radiofrequency neurotomy, involve the destruction of nerves using heat generated by radiofrequency currents. Known side effects of this treatment include increased pain, transient lower limb numbness, paraesthesias (abnormal sensations like tingling or prickling), and superficial burns. These side effects are generally transient, but it is important for patients to discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

Radiofrequency neurotomy, which involves the disruption of pain signals via heat generated by radio waves, is a treatment used for chronic neck pain, particularly in conditions like cervical facet joint pain. While specific FDA approvals for radiofrequency neurotomy for neck pain are not detailed, this technique is widely used in clinical practice. Other related treatments for neck pain include epidural steroid injections and various forms of nerve blocks, which are commonly used to manage chronic pain conditions. These interventions aim to reduce inflammation and interrupt pain signaling pathways, providing relief for patients with chronic neck pain.

What other types of research exist?

Promising novel alternatives to Radiofrequency Neurotomy for neck pain patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown effectiveness in reducing chronic pain. 2) Spinal Cord Stimulation (SCS), which has been effective in managing neuropathic pain. 3) Neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcutaneous supraorbital nerve stimulation, which have shown benefits in pain reduction and functional improvement.

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Procedure

Radiofrequency Neurotomy Techniques for Neck Pain (EndPaRL Trial)

N/A

Recruiting

Led By Anuj Bhatia, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Predominant axial (non-radicular) neck pain for at least 3 months

7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation

Must not have

Chronic widespread pain

Systemic or local infection at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week before the procedure and 1 month after the procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of needles for a heat-based treatment to relieve severe neck pain in patients with arthritis in specific neck joints. The treatment works by using heat to stop nerves from sending pain signals.

Who is the study for?

This trial is for adults aged 18-85 with chronic neck pain due to facet joint arthritis, who haven't found relief from standard treatments. They must have had a positive response to diagnostic nerve blocks and moderate functional impairment. Those with widespread pain, prior similar treatments, severe mental health issues, or conditions preventing fluoroscopy use like pregnancy can't join.

What is being tested?

The study compares two radiofrequency neurotomy techniques on nerves in the neck for treating chronic neck pain: one using a straight needle (parallel lesioning) and another using a trident needle (end-on lesioning). The goal is to see which method is more effective at reducing pain.

What are the potential side effects?

Potential side effects of the procedures may include temporary increased neck pain, numbness or tingling in the treated area, minor bleeding or bruising at the injection site, and less commonly infection or allergic reaction to anesthetics used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had mainly neck pain, not shooting pain, for over 3 months.

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My average neck pain score is 5 or more out of 10.

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My pain causes significant difficulty in my daily activities.

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My neck X-ray shows severe arthritis in the spine joints.

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My condition hasn't improved after 3 months of medication and physical therapy.

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I responded well to two nerve block tests with anesthesia.

Exclusion Criteria

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

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I experience pain in many parts of my body.

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I do not have any infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week before the procedure and 1 month after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week before the procedure and 1 month after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week before the procedure and 1 month after the procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Difference in mean Numerical Rating Scale (NRS) for pain scores

Secondary study objectives

Difference in average physical activity and sleep duration

Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure

Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome.

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RFN of CMBNn with end-on lesioning with multitIned trident cannulaeExperimental Treatment1 Intervention

Intervention type: RF nerve end-on lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae Intervention description: Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets

Group II: RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)Active Control1 Intervention

Intervention type: RF nerve parallel lesioning at 80-850 Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique) Intervention description: Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement

0 / 8Eligibility 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

The most common treatments for neck pain, such as ganglionectomy, conventional radiofrequency treatment, and pulsed radiofrequency treatment, primarily work by disrupting pain signals. Ganglionectomy involves the surgical removal of a ganglion to prevent pain transmission. Conventional radiofrequency treatment uses heat generated by radio waves to create a lesion on the nerve, thereby interrupting pain signals. Pulsed radiofrequency treatment, on the other hand, delivers short bursts of radiofrequency energy to modulate nerve function without causing significant tissue damage. These treatments are crucial for neck pain patients as they target the source of pain directly, offering potential relief when other methods are ineffective.

A systematic review: current and future directions of dorsal root ganglion therapeutics to treat chronic pain.