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

NCT ID: NCT04152954

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2023-02-20

Brief Summary

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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

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Conditions

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Neck Pain Radiofrequency Ablation Facet Joint Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Traditional cannula

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

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation of cervical medial branches

Intervention Type DEVICE

Radiofrequency ablation of cervical medial branches

Multi-tined cannula

Cervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach

Group Type EXPERIMENTAL

Radiofrequency ablation of cervical medial branches

Intervention Type DEVICE

Radiofrequency ablation of cervical medial branches

Interventions

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Radiofrequency ablation of cervical medial branches

Radiofrequency ablation of cervical medial branches

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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19.101

Identifier Type: -

Identifier Source: org_study_id

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