RecruitingNot ApplicableNCT05818774

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

A Prospective, Randomized, Double Blind Clinical Trial Comparing End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves: The EndPaRL Study

Sponsor

University Health Network, Toronto

Enrollment

72 participants

Start Date

Mar 10, 2023

Study Type

INTERVENTIONAL

Conditions

Neck Pain Zygapophyseal Joint Arthritis

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

Adult patient of either gender aged 18-85 years
Predominant axial (non-radicular) neck pain for at least 3 months
7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
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 Criteria8

Participants with financial incentives or litigation associated with ongoing pain
Inability to complete assessment instruments
Chronic widespread pain
Prior RFN of the CMBN;
Severe mental health issues
Pregnancy or other reason that precludes the use of fluoroscopy
Untreated coagulopathy
Systemic or local infection at the time of screening.

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Interventions

PROCEDURERadiofrequency 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

PROCEDURERadiofrequency 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.