Giovanni Leoni, Andrea Demeco, Claudia Correia, Afonso Braz, João Tocha, Xavier Melo, Tomás Caroço, Cosimo Costantino, Jorge Barbosa
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引用次数: 0
Abstract
Objectives: Genicular nerve radiofrequency ablation (RFA) efficacy for knee osteoarthritis (OA) remains debated. This prospective pilot study evaluated the feasibility and outcomes of a novel 5-nerve ultrasound-guided protocol targeting: Superior-Medial (SMGN), Superior-Lateral (SLGN), Inferior-Medial (IMGN), Inferior-Lateral (ILGN) Genicular Nerves and Recurrent Fibular Nerve (RFN).
Methods: Nineteen patients were enrolled. Feasibility was assessed through protocol adherence and safety (adverse events rate). Primary outcomes were pain (Numerical Rating Scale - NRS) and function (Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC) defining responders as ≥50% improvement. Secondary assessments included Environmental Quality of Life Scale (EQoL-5), 6-Minute Walk Test (6MWT), Timed-Up-and-Go (TUG), and Medical Research Council (MRC) scale at 1 and 3 months.
Results: Significant improvements occurred in NRS (p < 0.001), WOMAC (p < 0.001), and EQoL-Index (p = 0.003); responder rate was 63.2% (n = 12/19). One patient withdrew after T1 due to dissatisfaction; no study attrition or adverse events (notably motor deficits) occurred. Baseline 6MWT >200 m associated with treatment response (p = 0.048), though small sample size limits generalizability.
Conclusions: This 5-nerve protocol demonstrated clinical plausibility and safety. Lack of a control group precludes definitive attribution of improvements to RFA over placebo. Robust RCTs comparing 3-nerve vs. 5-nerve protocols are mandatory before clinical implementation.
目的:膝神经射频消融术(RFA)治疗膝骨关节炎(OA)的疗效仍有争议。这项前瞻性先导研究评估了一种新的5神经超声引导方案的可行性和结果:上内侧神经(SMGN)、上外侧神经(SLGN)、下内侧神经(IMGN)、下外侧神经(ILGN)膝神经和腓骨复发神经(RFN)。方法:纳入19例患者。通过方案依从性和安全性(不良事件发生率)评估可行性。主要结果是疼痛(数值评定量表- NRS)和功能(西安大略省和麦克马斯特大学骨关节炎指数- WOMAC),将缓解者定义为改善≥50%。第二次评估包括环境生活质量量表(EQoL-5)、6分钟步行测试(6MWT)、time - up -and- go (TUG)和医学研究委员会(MRC)量表。结果:NRS有显著改善(p p p = 0.003);应答率为63.2% (n = 12/19)。1例患者在T1后因不满意退出;没有研究损耗或不良事件(特别是运动缺陷)发生。基线6MWT >200 m与治疗反应相关(p = 0.048),尽管小样本量限制了普遍性。结论:该5神经治疗方案具有临床可行性和安全性。缺乏对照组排除了RFA优于安慰剂改善的明确归因。在临床实施之前,必须进行比较3-神经和5-神经方案的可靠随机对照试验。