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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
University Health Network (UHN)
RECRUITING
Toronto
Women's College Hospital
RECRUITING
Toronto
Spain
Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Danielle Alvares, PhD
danielle.alvares@uhn.ca
(416) 603-5800
Time Frame
Start Date:2023-03-10
Estimated Completion Date:2028-03
Participants
Target number of participants:72
Treatments
Experimental: RFN of CMBNn with end-on lesioning with multitIned trident cannulae
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
Active_comparator: RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)
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