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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Université de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
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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