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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.
Alomari, Abeer; Ferreira-Dos-Santos, Guilherme; Singh, Mandeep; Burnham, Taylor; Cao, Xingshan; McCormick, Zachary; Flamer, David; Kumar, Pranab; Hoydonckx, Yasmine; Khan, James S; Tumber, Paul S; Alvares, Danielle; Bhatia, Anuj.
Afiliación
  • Alomari A; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.
  • Ferreira-Dos-Santos G; Division of Pain Medicine, Department of Anesthesiology, Reanimation and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona, Calle de Villarroel, 170, 08036, Barcelona, Spain.
  • Singh M; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.
  • Burnham T; Department of Anesthesiology and Pain Medicine, University Health Network, Women's College Hospital, University of Toronto, Toronto, ON, Canada.
  • Cao X; Department of Physical Medicine and Rehabilitation, Spine and Musculoskeletal Rehabilitation Section, University of Utah, 50 North Medical Drive, Salt Lake City, UT, 84132, USA.
  • McCormick Z; Research Design and Biostatistics, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
  • Flamer D; Department of Physical Medicine and Rehabilitation, Spine and Musculoskeletal Rehabilitation Section, University of Utah, 50 North Medical Drive, Salt Lake City, UT, 84132, USA.
  • Kumar P; Department of Anesthesia and Pain Medicine, University of Toronto, Sinai Health System, Toronto, ON, Canada.
  • Hoydonckx Y; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.
  • Khan JS; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.
  • Tumber PS; Department of Anesthesia and Pain Medicine, University of Toronto, Sinai Health System, Toronto, ON, Canada.
  • Alvares D; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.
  • Bhatia A; Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.
Trials ; 24(1): 721, 2023 Nov 11.
Article en En | MEDLINE | ID: mdl-37951900
BACKGROUND: Cervical facet joint disease is a common source of neck pain and its prevalence increases with aging. Conservative multimodal management options (e.g., strengthening of neck muscles, non-steroidal anti-inflammatory medications, massage, and thermal modalities) often fail to relieve pain. Cervical medial branch nerve (CMBN) radiofrequency neurotomy (RFN) is an effective minimally invasive technique for treating chronic neck pain secondary to facet joint disease. An end-on approach for this procedure has been proposed that may be technically easier and require less time while reducing post-procedural discomfort. The protocol presented here is for a study that aims to compare the efficacy of a new end-on approach using multi-tined cannulae, against the conventional parallel technique that employs straight cannulae for RFN of the CMBN in patients with chronic neck pain due to cervical facet joint disease. METHODS: A multicentre randomized, non-inferior, active comparator-controlled trial will be conducted with two parallel groups and blinding of participants and outcome assessor. The study will include 72 adults with chronic neck pain secondary to facet joint disease who are candidates for RFA of the CMBN. Participants will be randomized to either the conventional parallel or the end-on approach in a 1:1 ratio. The intensity of pain and pain-related domains (function, quality of life, sleep, adverse effects of the interventions, analgesic intake) will be measured at 1, 3, 6, and 12 months after the procedure. DISCUSSION: Neck pain secondary to cervical facet joint disease is prevalent and RFA of the CMBN is a validated treatment for relieving it. The conventional parallel technique can be technically challenging, and it can be associated with adverse effects while the newer end-on approach has the potential of being a simpler technique with less adverse effects. This trial will be the first non-inferiority study to compare the clinical efficacy of the end-on approach against the conventional parallel approach for RFN of CMBN in patients with chronic neck pain due to cervical facet joint disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT05818774. Registered on April 20, 2023.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Articulación Cigapofisaria / Dolor Crónico / Artropatías / Bloqueo Nervioso Límite: Adult / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Articulación Cigapofisaria / Dolor Crónico / Artropatías / Bloqueo Nervioso Límite: Adult / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido