比较常规和冷却射频治疗膝关节神经与假手术治疗慢性膝关节疼痛患者的疗效：一项多中心、双盲、随机对照试验（COGENIUS）的方案。

Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS).

机构信息

Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium

Department of Anesthesiology and Pain Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands.

出版信息

BMJ Open. 2023 Aug 2;13(8):e073949. doi: 10.1136/bmjopen-2023-073949.

DOI:10.1136/bmjopen-2023-073949

PMID:37532482

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10401223/

Abstract

INTRODUCTION

The prevalence of chronic knee pain is increasing. Osteoarthritis (OA) and persistent postsurgical pain (PPSP) are two important causes of knee pain. Chronic knee pain is primarily treated with medications, physiotherapy, life-style changes and intra-articular infiltrations. A radiofrequency treatment (RF) of the genicular nerves is a therapeutical option for refractory knee pain. This study investigates the effectiveness and cost-effectiveness of conventional and cooled RF in patients suffering from chronic, therapy resistant, moderate to severe knee pain due to OA and PPSP.

METHODS AND ANALYSIS

The COGENIUS trial is a double-blinded, randomised controlled trial with 2-year follow-up. Patients and outcome assessors are blinded. Patients will be recruited and treated in Belgium and the Netherlands. All PPSP after a total knee prothesis and OA patients (grades 2-4) will undergo a run-in period of 1-3 months where conservative treatment will be optimised. After the run-in period, 200 patient per group will be randomised to conventional RF, cooled RF or a sham procedure following a 2:2:1 ratio. The analysis will include a comparison of the effectiveness of each RF treatment with the sham procedure and secondarily between conventional and cooled RF. All comparisons will be made for each indication separately. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index score at 6 months. Other outcomes include knee pain, physical functionality, health-related quality of life, emotional health, medication use, healthcare and societal cost and adverse events up to 24 months postintervention.

ETHICS AND DISSEMINATION

Ethics approval was obtained from the Ethics Committee of the University of Antwerp (Number Project ID 3069-Edge 002190-BUN B3002022000025), the Ethics committee of Maastricht University (Number NL80503.068.22-METC22-023) and the Ethics committee of all participating hospitals. Results of the study will be published in international peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT05407610.

摘要

简介

慢性膝关节疼痛的患病率正在上升。骨关节炎（OA）和持续性手术后疼痛（PPSP）是膝关节疼痛的两个重要原因。慢性膝关节疼痛主要通过药物治疗、物理治疗、生活方式改变和关节内浸润治疗。关节内神经射频治疗（RF）是治疗难治性膝关节疼痛的一种治疗选择。本研究旨在调查常规和冷却 RF 治疗 OA 和 PPSP 引起的慢性、治疗抵抗、中重度膝关节疼痛患者的有效性和成本效益。

方法和分析

COGENIUS 试验是一项为期 2 年随访的双盲、随机对照试验。患者和结果评估者均设盲。患者将在比利时和荷兰招募和治疗。所有膝关节置换术后持续性疼痛和 OA 患者（2-4 级）将进行 1-3 个月的预试验期，在此期间将优化保守治疗。预试验期后，将按照 2:2:1 的比例将每组 200 名患者随机分为常规 RF、冷却 RF 或假手术组。分析将包括比较每种 RF 治疗与假手术的疗效，其次是常规 RF 和冷却 RF 之间的疗效比较。所有比较将分别针对每种适应症进行。主要结局指标是 6 个月时的西部安大略省和麦克马斯特大学骨关节炎指数评分。其他结局指标包括膝关节疼痛、身体功能、健康相关生活质量、情绪健康、药物使用、医疗保健和社会成本以及 24 个月的不良事件。