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比较膝关节神经冷却与常规射频治疗慢性膝关节疼痛的多中心非劣效性随机先导试验(COCOGEN 试验)。

Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial).

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 UMC+, Maastricht, The Netherlands.

出版信息

Reg Anesth Pain Med. 2023 May;48(5):197-204. doi: 10.1136/rapm-2022-104054. Epub 2023 Jan 18.

DOI:10.1136/rapm-2022-104054
PMID:36653065
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10086476/
Abstract

BACKGROUND

Radiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking.

METHODS

This double blind, non-inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty. Patients were randomized following a 1:1 rate. The primary outcome was the proportion of patients with ≥50% pain reduction at 3 months postintervention. Other outcomes were knee pain, functionality, quality of life, emotional health, and adverse events up to 6 months postintervention. Conventional RF treatment was tested for non-inferiority to cooled in reducing knee pain at 3 months follow-up.

RESULTS

Forty-nine of 70 patients were included, of which 47 completed a 3-month follow-up. The primary outcome was achieved in 4 of 23 patients treated with conventional RF (17%) vs in 8 of 24 with cooled (33%) (p=0,21). Results from the non-inferiority comparison were inconclusive in relation to the non-inferiority margin. There was no statistically significant difference between secondary outcomes. There were no serious adverse events.

CONCLUSIONS

Both conventional and cooled RF treatment reduced pain in the osteoarthritis and persistent postsurgical pain population. This pilot study did not demonstrate statistically significant differences in the proportion of patients experiencing ≥50% pain reduction between techniques. The non-inferiority analysis was inconclusive. These results warrant further research.

TRIAL REGISTRATION NUMBER

NCT03865849.

摘要

背景

射频(RF)治疗关节神经有可能减轻因骨关节炎或全膝关节置换术后持续存在的手术相关疼痛引起的慢性膝关节疼痛,但缺乏对两种主要治疗模式(常规和冷却)的直接比较。

方法

这项双盲、非劣效性、前瞻性、随机对照试验比较了冷却和常规 RF 治疗骨关节炎或全膝关节置换术后持续存在的手术相关疼痛的慢性膝关节疼痛患者的疗效。患者按照 1:1 的比例随机分组。主要结局是干预后 3 个月时疼痛缓解≥50%的患者比例。其他结局包括膝关节疼痛、功能、生活质量、情绪健康以及干预后 6 个月内的不良事件。常规 RF 治疗被测试在减轻膝关节疼痛方面是否不劣于冷却,随访时间为 3 个月。

结果

70 例患者中纳入了 49 例,其中 47 例完成了 3 个月的随访。在接受常规 RF 治疗的 23 例患者中有 4 例(17%)和接受冷却 RF 治疗的 24 例患者中有 8 例(33%)达到了主要结局(p=0.21)。在与非劣效性边界的非劣效性比较中,结果不确定。次要结局无统计学差异。无严重不良事件。

结论

常规和冷却 RF 治疗均能减轻骨关节炎和持续手术相关疼痛人群的疼痛。这项初步研究未表明两种技术在疼痛缓解≥50%的患者比例方面存在统计学差异。非劣效性分析不确定。这些结果需要进一步研究。

试验注册号

NCT03865849。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/21ee7683be88/rapm-2022-104054f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/400d87997373/rapm-2022-104054f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/1d22511eeb77/rapm-2022-104054f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/21ee7683be88/rapm-2022-104054f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/400d87997373/rapm-2022-104054f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/1d22511eeb77/rapm-2022-104054f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5def/10086476/21ee7683be88/rapm-2022-104054f03.jpg

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