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 tests two different radiofrequency neurotomy techniques for treating chronic neck pain caused by arthritis in the neck joints. Researchers aim to determine which method more effectively reduces pain by comparing two types of needles. Individuals who have experienced neck pain for at least three months, find it affects daily life, and have not found relief from other treatments might be suitable candidates. Participants should also have shown pain relief from specific diagnostic blocks, which use anesthetic injections to confirm the pain source. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially find relief from chronic neck pain.

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.

What prior data suggests that these radiofrequency neurotomy techniques are safe for treating neck pain?

Research has shown that radiofrequency neurotomy (RFN) safely treats neck pain caused by joint problems. Studies have found that both the end-on and parallel techniques are well-tolerated by patients.

For the end-on method, which uses a special multitined trident needle, research suggests it effectively eases neck pain linked to certain neck joints. Evidence indicates that patients generally handle this technique well without serious side effects.

The parallel method, using a sharp straight needle, also has a good safety record. It is often used for neck pain and is usually well-tolerated, with most patients experiencing significant pain relief and few side effects.

Overall, both RFN techniques are considered relatively safe for treating neck pain related to joint issues, with patients typically experiencing pain relief without major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these radiofrequency neurotomy techniques for neck pain because they offer innovative approaches to targeting pain sources. Unlike traditional treatments, like medication or physical therapy, these methods involve precisely applying heat to nerve areas that transmit pain signals, aiming to disrupt them. The first technique uses a multitined trident cannula for end-on lesioning, potentially providing more comprehensive coverage of the nerve area. Meanwhile, the parallel lesioning technique with a sharp straight cannula follows specific guidelines that might offer a more consistent application. These methods could offer more effective pain relief for patients with chronic neck pain compared to current options.

What evidence suggests that these radiofrequency neurotomy techniques are effective for neck pain?

Research shows that radiofrequency neurotomy (RFN) effectively treats neck pain caused by arthritis in the neck joints. Studies found that patients experienced an average pain reduction of 86% lasting about 9 months. In this trial, participants will receive either the end-on method using special needles, which showed that 65.4% of patients felt significant pain relief three months after treatment, or the parallel method, which demonstrated up to 57% success in pain relief in past studies. These findings suggest that RFN, using either method, can significantly reduce neck pain for many patients. ^{3 5 6 7 8}

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

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 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]

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 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10638800/

End-on versus parallel radiofrequency lesioning ... A study that aims to compare the efficacy of a new end-on approach using multi-tined cannulae, against the conventional parallel technique.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000330

The effectiveness of cervical medial branch radiofrequency ... Patients with successful treatment outcomes whose index symptoms eventually returned reported an average pain reduction of 86 % lasting approximately 9 months.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9686245/

A Systematic Review and Meta-analysis of the Effectiveness of ... The objective of this systematic review and meta-analysis is to evaluate the effectiveness of radiofrequency neurotomy as a therapeutic cervical facet joint ...

4. researchgate.net researchgate.net/publication/375583173_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

(PDF) End-on versus parallel radiofrequency lesioning for ... At 3 months post-procedure, ≥50 % NRS pain reduction and MCID on PDQQ-S were both reported by 34 patients (65.4 % [95%CI 51.8–76.9]). Of the 34 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000846

Assessment of real-world, prospective outcomes in patients ... A systematic review and meta-analysis of the effectiveness of radiofrequency neurotomy in managing chronic neck pain. Pain Ther, 12 (1) (2023 Feb), pp. 19-66.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11978372/

The effectiveness of cervical medial branch radiofrequency ... Cervical medial branch radiofrequency neurotomy is a relatively safe and effective treatment for zygapophyseal joint-mediated neck pain.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423001048

Randomized controlled trial comparing technical features ... Patients who responded to dual medial branch blocks with ≥75% pain relief were randomized to receive RFN with either the MTC or the CC. Primary outcomes: ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05424198

Trident Multi-tined Cannula for Cervical MBRFA Compared ... Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies ...