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

Not Applicable

Completed

• Conditions: Facet Joint Pain; Radiofrequency Ablation; Neck Pain
• Interventions: Device: Radiofrequency ablation of cervical medial branches

• Registration Number: NCT04152954
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Study Start: 2019-12-04
• Primary Completion: 2022-02-16
• Study Completion: 2023-02-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-tined cannula	Radiofrequency ablation of cervical medial branches	Cervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach
Traditional cannula	Radiofrequency ablation of cervical medial branches	Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach.

Primary Outcome Measures

Name	Time	Method
Numerical Pain Rating scale for patient's pain during the procedure	1 day of the intervention	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Université de Montréal; 🇨🇦 Montréal, Quebec, Canada