End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves
NCT ID: NCT05818774
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2023-03-10
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RFN of CMBNn with end-on lesioning with multitIned trident cannulae
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
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
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.
RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)
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
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning
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
Interventions
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Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning
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
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
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.
Eligibility Criteria
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Inclusion Criteria
2. Predominant axial (non-radicular) neck pain for at least 3 months
3. 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
4. Moderate or greater functional impairment due to pain, defined as NDI Questionnaire raw score of 15 out of 50 (≥30% )e Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months;
f) Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic
Exclusion Criteria
2. Inability to complete assessment instruments
3. Chronic widespread pain
4. Prior RFN of the CMBN;
5. Severe mental health issues
6. Pregnancy or other reason that precludes the use of fluoroscopy
7. Untreated coagulopathy
8. Systemic or local infection at the time of screening.
18 Years
85 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Anuj Bhatia
Associate Professor
Principal Investigators
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Anuj Bhatia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Pain Management, University Health Network, Toronto
Locations
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Women's College Hospital
Toronto, Ontario, Canada
University Health Network (UHN)
Toronto, Ontario, Canada
Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Anuj Bhatia
Role: primary
Didem Bozak
Role: backup
Danielle Alvares, PhD
Role: primary
Guilherme Ferreira Dos Santos, MD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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22-5634
Identifier Type: -
Identifier Source: org_study_id