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

Not Applicable

Recruiting

• Conditions: Zygapophyseal Joint Arthritis; Neck Pain
• Interventions: 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

• Registration Number: NCT05818774
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)	Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning	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
RFN of CMBNn with end-on lesioning with multitIned trident cannulae	Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (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

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Difference in the mean Numerical Rating Scale (NRS) for pain scores	at 1, 6 and 12 months	Difference in mean NRS for pain scores at 1, 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome
Proportion of patients with positive analgesic response	at 1,3, 6 and 12 months	Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 1,3, 6 \& 12 months
Proportion of patients with reduction in the Neck Disability Index (NDI) score	at 1, 3, 6, and 12 months	Proportion of patients with ≥10% reduction in the NDI score at 1, 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome
Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale	at 1, 3, 6, and 12 months	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 1, 3, 6, and 12 months
Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality	at 1, 3, 6, and 12 months	Difference in mean PSQI scores scores at 1, 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality.
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.	at 1, 3, 6, and 12 months	Difference in mean EQ-5D-5L scores at 3, 6, and 12 months
Differences in duration of procedure between 2 groups	day of procedure	Differences in duration of procedure in two groups
Differences in discomfort procedure between 2 groups	day of procedure	Differences in patient discomfort of procedure
Differences in radiation dose of procedure between 2 groups	day of procedure	Differences in radiation dose of procedure
Differences in cost of procedure between 2 groups	day of procedure	Differences in cost of the procedures
Difference in opioid requirements in daily oral morphine equivalents between the groups	at 3, 6, and 12 months follow-ups after the procedure	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
Difference in average physical activity and sleep duration	1 week before the procedure and 1 month after the procedure	Difference in average physical activity and sleep duration as measured by wrist-worn actigraphy worn for 1 week before the procedure and 1 month after the procedure
Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure	at 1, 3, 6, and 12 months after the procedures	Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure in the two groups during and at 1, 3, 6, and 12 months after the procedures
Patient assumption of the group assigned	at 3 months after procedure	Patient assumption of the group assigned at 3 months after the RFN procedure

Trial Locations

Locations (3)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada

Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.; 🇪🇸 Barcelona, Catalonia, Spain

University Health Network (UHN); 🇨🇦 Toronto, Ontario, Canada