Radiofrequency Neurotomy Techniques for Neck Pain

(EndPaRL Trial)

Recruiting at 2 trial locations

Overseen By Danielle Alvares, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Chronic widespread pain, Severe mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is radiofrequency neurotomy for neck pain generally safe for humans?

The available research does not provide specific safety data for radiofrequency neurotomy, but it is described as a minimally invasive technique for treating chronic neck pain, suggesting it is generally considered safe when performed by trained practitioners. ^{1 2 3 4 5}

How is radiofrequency neurotomy for neck pain different from other treatments?

Radiofrequency neurotomy (RFN) for neck pain is unique because it uses heat to target and disrupt specific nerves responsible for transmitting pain signals, offering a minimally invasive option for chronic neck pain relief. The end-on lesioning technique with multitined trident cannulae may be easier and quicker to perform, potentially reducing discomfort after the procedure compared to the traditional parallel technique. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for neck pain?

Research indicates that cervical medial branch radiofrequency neurotomy (RFN) is an effective minimally invasive treatment for chronic neck pain caused by facet joint disease, especially when other conservative treatments fail. A study protocol suggests that an end-on approach using multi-tined cannulae may be easier and quicker, potentially reducing discomfort after the procedure. ^{1 2 3 4 5}

Who Is on the Research Team?

Anuj Bhatia, MD, PhD

Principal Investigator

Department of Anesthesia and Pain Management, University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

My pain causes significant difficulty in my daily activities.

Exclusion Criteria

You have previously received radiofrequency neurotomy for chronic mechanical back pain.

I experience pain in many parts of my body.

You have serious mental health problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radiofrequency neurotomy of Cervical Medial Branch Nerves using either end-on or parallel lesioning techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
• Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning

Trial Overview 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.

How Is the Trial Designed?

Group I: RFN of CMBNn with end-on lesioning with multitIned trident cannulae Experimental Treatment 1 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 Control 1 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

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Radiofrequency Neurotomy for:

• Chronic neck pain due to cervical zygapophyseal joint osteoarthritis

Approved in European Union as Radiofrequency Neurotomy for:

• Chronic neck pain due to cervical zygapophyseal joint osteoarthritis

Approved in Canada as Radiofrequency Neurotomy for:

• Chronic neck pain due to cervical zygapophyseal joint osteoarthritis

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

In a study of 27 patients undergoing lumbar medial branch radiofrequency neurotomy (RFN), significant disc degeneration was observed at treated levels compared to untreated levels, indicating a potential adverse effect of the procedure on intervertebral discs.

No changes were found in the cross-sectional area of the multifidus muscle or in the degeneration of facet joints, suggesting that while RFN may impact disc health, it does not appear to affect muscle size or joint deterioration in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study. Smuck, M., Crisostomo, RA., Demirjian, R., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 104 patients with chronic neck pain, cervical medial branch radiofrequency neurotomy (RFN) resulted in successful outcomes for 74% and 61% of patients in two different practices, demonstrating its effectiveness when performed by trained practitioners.

Patients experienced significant pain relief lasting between 17 to 20 months after the first RFN treatment, with about 60% maintaining relief at follow-up, indicating that RFN can provide long-term benefits for managing chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical medial branch radiofrequency neurotomy in New Zealand. MacVicar, J., Borowczyk, JM., MacVicar, AM., et al.[2022]

An ultrasound-guided technique for radiofrequency cervical medial branch neurotomy was successfully developed and validated in a study involving five fresh cadavers, achieving accurate needle placements in all targeted cervical segments.

The technique resulted in successful neurotomy in 30 out of 34 cervical medial branches, indicating its potential efficacy, but further validation in symptomatic patients is necessary before eliminating the use of fluoroscopy for needle positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided radiofrequency neurotomy in cervical spine: sonoanatomic study of a new technique in cadavers. Lee, SH., Kang, CH., Lee, SH., et al.[2019]

In a study of 28 patients with chronic neck pain, 71% experienced complete pain relief after the initial percutaneous radiofrequency medial branch neurotomy, indicating its efficacy as a treatment option.

The median duration of pain relief was 219 days for all patients and 422 days for those who responded successfully, with repeat procedures able to restore relief if pain returned, highlighting the long-term benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients treated with cervical radiofrequency neurotomy for chronic neck pain. McDonald, GJ., Lord, SM., Bogduk, N.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Cervical medial branch radiofrequency neurotomy in New Zealand. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided radiofrequency neurotomy in cervical spine: sonoanatomic study of a new technique in cadavers. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients treated with cervical radiofrequency neurotomy for chronic neck pain. [2022]