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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04152954
Other study ID # 19.101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2019
Est. completion date February 20, 2023

Study information

Verified date March 2023
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 20, 2023
Est. primary completion date February 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Radiofrequency ablation of cervical medial branches
Radiofrequency ablation of cervical medial branches

Locations

Country Name City State
Canada Centre Hospitalier Université de Montréal Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Fluoroscopy time Calculated time of fluoroscopy in seconds 1 day of the intervention
Secondary Radiation dosage Calculated dose of radiation measure by the C-arm 1 day of the intervention
Secondary time of procedure Total time of procedure in minutes/seconds 1 day of the intervention
Secondary 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
Secondary 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
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