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

NCT05818774 | Recruiting

• 1 other identifier: 22-5634
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 3

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.

Conditions

Neck Pain; Zygapophyseal Joint Arthritis

Keywords

Radiofrequency neurotomy; Cervical Medial Branch Nerves

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Difference in the mean Numerical Rating Scale (NRS) for pain scores

  at 1, 6 and 12 months

• Proportion of patients with positive analgesic response

  at 1,3, 6 and 12 months

• Proportion of patients with reduction in the Neck Disability Index (NDI) score

  at 1, 3, 6, and 12 months

• Proportion of participants reporting improvement in the Patient Global Impression of Change (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

Study Arms (2)

RFN of CMBNn with end-on lesioning with multitIned trident cannulae

EXPERIMENTAL

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

RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)

ACTIVE COMPARATOR

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

Interventions

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae PROCEDURE

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.

RFN of CMBNn with end-on lesioning with multitIned trident cannulae

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning PROCEDURE

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

RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient of either gender aged 18-85 years
• Predominant axial (non-radicular) neck pain for at least 3 months
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

Women's College Hospital

Toronto, Ontario, M5S 1B3, Canada

RECRUITING

University Health Network (UHN)

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.

Barcelona, Catalonia, 08036, Spain

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 22458772 BACKGROUND

• 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.

  PMID: 8929263 RESULT

• 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.

  PMID: 16083457 RESULT

• Alomari A, Ferreira-Dos-Santos G, Singh M, Burnham T, Cao X, McCormick Z, Flamer D, Kumar P, Hoydonckx Y, Khan JS, Tumber PS, Alvares D, Bhatia A. End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-07752-9.

  PMID: 37951900 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Denervation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Anuj Bhatia, MD, PhD

  Department of Anesthesia and Pain Management, University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Alvares, PhD

CONTACT

(416) 603-5800; danielle.alvares@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: March 10, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); ES (1)