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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain; Zygapophyseal Joint Arthritis
• Intervention / Treatment: Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae; Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kawal Singh; Phone Number: 3959 (416) 603-5800; Email: kawalpreet.singh@uhnresearch.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • University Health Network (UHN)
      • Contact: Kawal Singh; Phone Number: 3959 4166035118; Email: kawalpreet.singh@uhnresearch.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%
5. Cervical spine imaging compatible with Pathria's grade 3 or grade 4 zygapophyseal joint osteoarthritis
6. Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months;
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: 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.
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	Procedure: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Anuj Bhatia, MD, PhD, Department of Anesthesia and Pain Management, University Health Network, Toronto

Publications and helpful links

General Publications

• MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.
• Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302.
• Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Radiofrequency neurotomy; Cervical Medial Branch Nerves
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 22-5634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the IPD at the moment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No