End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves

NCT05818774 · tracked via the Priya Life Science Spain tracker

Sponsor

University Health Network, Toronto

Phase

Not applicable

Started

2023-03-10

Last updated

2026-01-16

Condition(s) studied

Neck PainZygapophyseal Joint Arthritis

Investigational drug(s) / intervention(s)

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioningRadiofrequency 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: Intervention type: RF nerve lesioning at 80-85 degree 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: Intervention type: RF nerve lesioning 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.

Study summary

Aim of the EndPaRL study is to compare the efficacy and effectiveness of the two techniques utilizing sharp straight conventional radiofrequency needle with a trident needle for radiofrequency neurotomy of Cervical Medial Branch Nerves (CMBNs), in patients presenting with chronic, moderate-to-severe, neck pain due to cervical zygapophyseal joint osteoarthritis, as diagnosed by positive responses to two consecutive diagnostic blocks with local anesthetic of the CMBN.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: 1. Adult patient of either gender aged 18-85 years 2. Predominant axial (non-radicular) neck pain for at least 3 months 3. 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation 4. Moderate or greater functional impairment due to pain, defined as NDI Questionnaire raw score of 15 out of 50 (≥30% )e Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months; f) Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic Exclusion Criteria: 1. Participants with financial incentives or litigation associated with ongoing pain 2. Inability to complete assessment instruments 3. Chronic widespread pain 4. Prior RFN of the CMBN; 5. Severe mental health issues 6. Pregnancy or other reason that precludes the use of fluoroscopy 7. Untreated coagulopathy 8. Systemic or local infection at the time of screening.

Primary outcome measure(s)

Difference in mean Numerical Rating Scale (NRS) for pain scores — 3 months
Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome
Proportion of patients with positive analgesic response — 3 months
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)

Trial sites (3)

Facility	City	Region	Status
Women's College Hospital	Toronto	Ontario	Recruiting
University Health Network (UHN)	Toronto	Ontario	Recruiting
Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.	Barcelona	Catalonia	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05818774 on ClinicalTrials.gov ↗ ← All trials in Spain