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Aim of the EndPaRL study is to compare the efficacy and effectiveness of the two techniques utilizing sharp straight conventional radiofrequency needle with a trident needle for radiofrequency neurotomy of Cervical Medial Branch Nerves (CMBNs), in patients presenting with chronic, moderate-to-severe, neck pain due to cervical zygapophyseal joint osteoarthritis, as diagnosed by positive responses to two consecutive diagnostic blocks with local anesthetic of the CMBN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFN of CMBNn with end-on lesioning with multitIned trident cannulae | Experimental | Intervention type: RF nerve end-on lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae Intervention description: Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets |
|
| RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique) | Active Comparator | Intervention type: RF nerve parallel lesioning at 80-850 Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique) Intervention description: Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning | Procedure | Intervention type: RF nerve lesioning at 80-85 degree Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique) Intervention description: Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean Numerical Rating Scale (NRS) for pain scores | Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome | 3 months |
| Proportion of patients with positive analgesic response | Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the mean Numerical Rating Scale (NRS) for pain scores | Difference in mean NRS for pain scores at 1, 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome | at 1, 6 and 12 months |
| Proportion of patients with positive analgesic response |
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Inclusion Criteria:
f) Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Alvares, PhD | Contact | (416) 603-5800 | 3517 | danielle.alvares@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anuj Bhatia, MD, PhD | Department of Anesthesia and Pain Management, University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Recruiting | Toronto | Ontario | M5S 1B3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22458772 | Background | MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28. | |
| 8929263 | Result | Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302. |
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There is no plan to share the IPD at the moment
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|
| Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae | Procedure | Intervention type: RF nerve lesioning lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae Intervention description: Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets. |
|
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 1,3, 6 & 12 months |
| at 1,3, 6 and 12 months |
| Proportion of patients with reduction in the Neck Disability Index (NDI) score | Proportion of patients with ≥10% reduction in the NDI score at 1, 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome | at 1, 3, 6, and 12 months |
| Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale | PGIC score is a 7 point scale depicting a patient's subjective rating of overall improvement over time, as proportion of participants reporting improvement in the PGIC scale at 1, 3, 6, and 12 months | at 1, 3, 6, and 12 months |
| Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality | Difference in mean PSQI scores scores at 1, 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality. | at 1, 3, 6, and 12 months |
| Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome. | Difference in mean EQ-5D-5L scores at 3, 6, and 12 months | at 1, 3, 6, and 12 months |
| Differences in duration of procedure between 2 groups | Differences in duration of procedure in two groups | day of procedure |
| Differences in discomfort procedure between 2 groups | Differences in patient discomfort of procedure | day of procedure |
| Differences in radiation dose of procedure between 2 groups | Differences in radiation dose of procedure | day of procedure |
| Differences in cost of procedure between 2 groups | Differences in cost of the procedures | day of procedure |
| Difference in opioid requirements in daily oral morphine equivalents between the groups | Difference in opioid requirements in daily oral morphine equivalents in mg averaged over the 1 week before and at 3, 6, and 12 months follow-ups after the procedure | at 3, 6, and 12 months follow-ups after the procedure |
| Difference in average physical activity and sleep duration | Difference in average physical activity and sleep duration as measured by wrist-worn actigraphy worn for 1 week before the procedure and 1 month after the procedure | 1 week before the procedure and 1 month after the procedure |
| Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure | Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure in the two groups during and at 1, 3, 6, and 12 months after the procedures | at 1, 3, 6, and 12 months after the procedures |
| Patient assumption of the group assigned | Patient assumption of the group assigned at 3 months after the RFN procedure | at 3 months after procedure |
| University Health Network (UHN) | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
|
| Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona. | Not yet recruiting | Barcelona | Catalonia | 08036 | Spain |
|
| 16083457 | Result | Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x. |
| 37951900 | Derived | Alomari A, Ferreira-Dos-Santos G, Singh M, Burnham T, Cao X, McCormick Z, Flamer D, Kumar P, Hoydonckx Y, Khan JS, Tumber PS, Alvares D, Bhatia A. End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-07752-9. |
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003714 | Denervation |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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