Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain

Chronic neck pain is a common disorder for spine specialists. Radiofrequency ablation of medial branches has been proven effective in selected patients for relieving pain. A newer radiofrequency ablation cannula has been developed (multi-tined), allowing perpendicular access. It is proposed as an alternative to the more technically challenging traditional approach. This study aims to compared the technical and clinical aspects of both techniques.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Facet Joint Pain; Radiofrequency Ablation
• Intervention / Treatment: Device: Radiofrequency ablation of cervical medial branches

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hospitalier Universite de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older
• Cervical neck pain at least 4/10 at rest or with activity
• Neck pain lasting at least 6 months and refractory to conservative treatments
• Neck pain is primarily axial (more than upper extremity)
• Success to medial branch block protocol

Exclusion Criteria:

• failure to medial branch block protocol (pain relief less than 75% on 2 occasions)
• Cervical neck pain less than 4/10
• Neurological deficits of upper extremity
• neuropathic pain of upper extremity
• pregnancy or breastfeeding
• inflammatory or neoplastic lesion on x-ray
• neck cortisone injection in last 3 months
• any medical or psychiatric condition contra-indicated for radiofrequency ablation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional cannula; Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach.	Device: Radiofrequency ablation of cervical medial branches; Radiofrequency ablation of cervical medial branches
Experimental: Multi-tined cannula; Cervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach	Device: Radiofrequency ablation of cervical medial branches; Radiofrequency ablation of cervical medial branches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating scale for patient's pain during the procedure	pain during radiofrequency procedure will be compared between the 2 groups as a principal hypothesis is that the new multi-tined cannula is better tolerated by patients Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10	1 day of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient pain (Numerical Rating Scale - NRS score)	therapeutic effect on pain Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10	0, 3, 6 12 months
Patient function (Neck disability Index - NDI)	therapeutic effect on function scale is from 0-100%, where 0% is better than 100% in terms of the effect of pain on function	0, 3, 6, 12 months
Fluoroscopy time	Calculated time of fluoroscopy in seconds	1 day of the intervention
Radiation dosage	Calculated dose of radiation measure by the C-arm	1 day of the intervention
time of procedure	Total time of procedure in minutes/seconds	1 day of the intervention

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): February 16, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Neck Pain
• Other Study ID Numbers: 19.101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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