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

NCT04152954 | Completed

• 1 other identifier: 19.101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Radiofrequency Ablation; Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fluoroscopy time

  1 day of the intervention

• Radiation dosage

  1 day of the intervention

• time of procedure

  1 day of the intervention

• Patient pain (Numerical Rating Scale - NRS score)

  0, 3, 6 12 months

• Patient function (Neck disability Index - NDI)

  0, 3, 6, 12 months

Study Arms (2)

Traditional cannula

ACTIVE COMPARATOR

Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach.

Device: Radiofrequency ablation of cervical medial branches

Multi-tined cannula

EXPERIMENTAL

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

Interventions

Radiofrequency ablation of cervical medial branches DEVICE

Radiofrequency ablation of cervical medial branches

Multi-tined cannula; Traditional cannula

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 6, 2019
• Study Start: December 4, 2019
• Primary Completion: February 16, 2022
• Study Completion: February 20, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)