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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152954
• Other study ID #: 19.101
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthralgia
• Facet Joint Pain
• Neck Pain
• Radiofrequency Ablation

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