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

Primary Purpose

Neck Pain, Radiofrequency Ablation, Facet Joint Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Radiofrequency ablation of cervical medial branches
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional cannula

Multi-tined cannula

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fluoroscopy time
Calculated time of fluoroscopy in seconds
Radiation dosage
Calculated dose of radiation measure by the C-arm
time of procedure
Total time of procedure in minutes/seconds
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
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

Full Information

First Posted
November 1, 2019
Last Updated
March 10, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04152954
Brief Title
Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain
Official Title
Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Radiofrequency Ablation, Facet Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional cannula
Arm Type
Active Comparator
Arm Description
Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach.
Arm Title
Multi-tined cannula
Arm Type
Experimental
Arm Description
Cervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation of cervical medial branches
Intervention Description
Radiofrequency ablation of cervical medial branches
Primary Outcome Measure Information:
Title
Numerical Pain Rating scale for patient's pain during the procedure
Description
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
Time Frame
1 day of the intervention
Secondary Outcome Measure Information:
Title
Fluoroscopy time
Description
Calculated time of fluoroscopy in seconds
Time Frame
1 day of the intervention
Title
Radiation dosage
Description
Calculated dose of radiation measure by the C-arm
Time Frame
1 day of the intervention
Title
time of procedure
Description
Total time of procedure in minutes/seconds
Time Frame
1 day of the intervention
Title
Patient pain (Numerical Rating Scale - NRS score)
Description
therapeutic effect on pain Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10
Time Frame
0, 3, 6 12 months
Title
Patient function (Neck disability Index - NDI)
Description
therapeutic effect on function scale is from 0-100%, where 0% is better than 100% in terms of the effect of pain on function
Time Frame
0, 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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