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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

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....

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638800/
https://www.ncbi.nlm.nih.gov/pubmed/37951900
http://dx.doi.org/10.1186/s13063-023-07752-9
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author 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
author_facet 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
author_sort Alomari, Abeer
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07752-9.
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spelling pubmed-106388002023-11-11 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 Trials Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07752-9. BioMed Central 2023-11-11 /pmc/articles/PMC10638800/ /pubmed/37951900 http://dx.doi.org/10.1186/s13063-023-07752-9 Text en © Crown 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638800/
https://www.ncbi.nlm.nih.gov/pubmed/37951900
http://dx.doi.org/10.1186/s13063-023-07752-9
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