Facet Joint Pain, Neck Pain, Radiofrequency Ablation
Conditions
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.
Interventions
DEVICERadiofrequency ablation of cervical medial branches
Radiofrequency ablation of cervical medial branches
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating scale for patient's pain during the procedure | 1 day of the intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy time | 1 day of the intervention | Calculated time of fluoroscopy in seconds |
| Radiation dosage | 1 day of the intervention | Calculated dose of radiation measure by the C-arm |
| time of procedure | 1 day of the intervention | Total time of procedure in minutes/seconds |
| Patient pain (Numerical Rating Scale - NRS score) | 0, 3, 6 12 months | 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) | 0, 3, 6, 12 months | therapeutic effect on function scale is from 0-100%, where 0% is better than 100% in terms of the effect of pain on function |
Countries
Canada
Outcome results
None listed