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

Study Overview
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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.

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

Conditions
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Neck Pain, Radiofrequency Ablation, Facet Joint Pain

Intervention / Treatment
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* Device: Radiofrequency ablation of cervical medial branches


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional cannula<br>Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach. | Device: Radiofrequency ablation of cervical medial branches<br>* Radiofrequency ablation of cervical medial branches<br>|
| Experimental: Multi-tined cannula<br>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<br>* Radiofrequency ablation of cervical medial branches<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time | Calculated time of fluoroscopy in seconds | 1 day of the intervention | 
| Radiation dosage | Calculated dose of radiation measure by the C-arm | 1 day of the intervention | 
| time of procedure | Total time of procedure in minutes/seconds | 1 day of the intervention | 
| 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 | 
| 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 |