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

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• Difference in mean Numerical Rating Scale (NRS) for pain scores [Time frame: 3 months]
• Proportion of patients with positive analgesic response [Time frame: 3 months]

Secondary outcome measures (12)

• Difference in the mean Numerical Rating Scale (NRS) for pain scores [Time frame: at 1, 6 and 12 months]
• Proportion of patients with positive analgesic response [Time frame: at 1,3, 6 and 12 months]
• Proportion of patients with reduction in the Neck Disability Index (NDI) score [Time frame: at 1, 3, 6, and 12 months]
• Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale [Time frame: at 1, 3, 6, and 12 months]
• Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality [Time frame: at 1, 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. [Time frame: at 1, 3, 6, and 12 months]
• Differences in duration of procedure between 2 groups [Time frame: day of procedure]
• Differences in discomfort procedure between 2 groups [Time frame: day of procedure]
• Differences in radiation dose of procedure between 2 groups [Time frame: day of procedure]
• Differences in cost of procedure between 2 groups [Time frame: day of procedure]
• Difference in opioid requirements in daily oral morphine equivalents between the groups [Time frame: at 3, 6, and 12 months follow-ups after the procedure]
• Difference in average physical activity and sleep duration [Time frame: 1 week before the procedure and 1 month after the procedure]

Eligibility criteria

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% )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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 2 centers

• Women's College Hospital — Toronto
• University Health Network (UHN) — Toronto

Spain · 1 center

• Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, H — Barcelona

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. PMID 22458772
• 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
• 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
• 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/s13063-023-0 PMID 37951900

Identifiers

NCT: NCT05818774 · 22-5634

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗