经皮颈椎内侧支射频神经切断术：前瞻性、随机、双盲临床试验研究方案：“EndPaRL”研究。

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.

机构信息

Department of Anesthesia and Pain Medicine, University of Toronto, Toronto Western Hospital, McL 2-405, 399 Bathurst Street, Toronto, Ontario, M5T 2S8, Canada.

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.

出版信息

Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-07752-9.

DOI:10.1186/s13063-023-07752-9

PMID:37951900

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10638800/

Abstract

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.

摘要

背景

颈椎小关节疾病是颈部疼痛的常见病因，其患病率随着年龄的增长而增加。保守的多模式管理选择（例如，颈部肌肉强化、非甾体抗炎药、按摩和热疗）通常无法缓解疼痛。颈椎内侧支神经（CMBN）射频神经切断术（RFN）是治疗小关节疾病引起的慢性颈痛的一种有效微创技术。已经提出了一种针对该手术的顺行入路方法，该方法可能在技术上更简单，所需时间更短，同时减少术后不适。本方案是一项旨在比较新型顺行多齿套管入路与传统平行技术治疗因颈椎小关节疾病引起的慢性颈痛患者 CMBN 的 RFN 的疗效的研究。

方法

这是一项多中心、随机、非劣效性、活性对照试验，将采用平行分组和参与者及结果评估者双盲设计。该研究将纳入 72 例因小关节疾病引起的慢性颈痛患者。将参与者按照 1:1 的比例随机分配至传统平行组或顺行组。在术后 1、3、6 和 12 个月时，测量疼痛强度和疼痛相关的领域（功能、生活质量、睡眠、干预的不良反应、镇痛药摄入）。

讨论

颈椎小关节疾病引起的颈痛较为常见，CMBN 的 RFA 是缓解疼痛的有效治疗方法。传统的平行技术可能具有挑战性，并且可能与不良反应相关，而新型的顺行方法有可能是一种更简单、不良反应更少的技术。本试验将是首例比较顺行入路与传统平行入路治疗因颈椎小关节疾病引起的慢性颈痛患者 CMBN 的 RFN 的临床疗效的非劣效性研究。