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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neck Pain, Zygapophyseal Joint Arthritis

Intervention / Treatment
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* Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning
* Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Cervical spine imaging compatible with Pathria's grade 3 or grade 4 zygapophyseal joint osteoarthritis Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months; Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFN of CMBNn with end-on lesioning with multitIned trident cannulae<br>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 | Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae<br>* 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.<br>|
| Active Comparator: RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)<br>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 | Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the mean Numerical Rating Scale (NRS) for pain scores | Difference in mean NRS for pain scores at 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome | at 6 and 12 months | 
| Proportion of patients with positive analgesic response | Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 6 & 12 months | at 6 and 12 months | 
| Proportion of patients with reduction in the Neck Disability Index (NDI) score | Proportion of patients with ≥10% reduction in the NDI score at 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome | at 3, 6, and 12 months | 
| Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale | PGIC score is a 7 point scale depicting a patient's subjective rating of overall improvement over time, as proportion of participants reporting improvement in the PGIC scale at 3, 6, and 12 months | at 3, 6, and 12 months | 
| Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality | Difference in mean PSQI scores scores at 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality. | at 3, 6, and 12 months | 
| Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome. | Difference in mean EQ-5D-5L scores at 3, 6, and 12 months | at 3, 6, and 12 months | 
| Differences in duration of procedure between 2 groups | Differences in duration of procedure in two groups | day of procedure | 
| Differences in discomfort procedure between 2 groups | Differences in patient discomfort of procedure | day of procedure | 
| Differences in radiation dose of procedure between 2 groups | Differences in radiation dose of procedure | day of procedure | 
| Differences in cost of procedure between 2 groups | Differences in cost of the procedures | day of procedure | 
| Difference in opioid requirements in daily oral morphine equivalents between the groups | Difference in opioid requirements in daily oral morphine equivalents in mg averaged over the 1 week before and at 3, 6, and 12 months follow-ups after the procedure | at 3, 6, and 12 months follow-ups after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency neurotomy, Cervical Medial Branch Nerves