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前瞻性、多中心、随机、交叉临床试验比较了冷却射频消融与皮质类固醇注射治疗骨关节炎膝关节疼痛的安全性和有效性。

Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.

出版信息

Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

DOI:10.1097/AAP.0000000000000690
PMID:29095245
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5768219/
Abstract

BACKGROUND AND OBJECTIVES

Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.

METHODS

This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.

RESULTS

There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.

CONCLUSIONS

This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov (NCT02343003).

摘要

背景与目的

膝关节骨关节炎(OA)影响老年人群体,对医疗保健系统有相关影响。缺乏评估射频消融术治疗 OA 相关膝关节疼痛的严格研究。本研究比较了冷却射频消融术(CRFA)与关节内皮质类固醇(IAS)注射治疗 OA 相关膝关节疼痛的长期临床安全性和有效性。

方法

这是一项前瞻性、多中心、随机试验,纳入 151 例慢性(≥6 个月)膝关节疼痛且对保守治疗无反应的患者。在干预后 1、3 和 6 个月,比较 CRFA 组和 IAS 组的膝关节疼痛(数字评分量表[NRS])、牛津膝关节评分、总体治疗效果(整体感知效果)、镇痛药使用情况和不良事件。

结果

研究组间在人口统计学方面无差异。在 6 个月时,CRFA 组在 NRS 方面具有更好的结果:疼痛减轻 50%或更多:74.1%比 16.2%,P<0.0001(分别为 25.9%和 83.8%的研究队列无反应)。NRS 评分平均降低 4.9±2.4 比 1.3±2.2,P<0.0001;牛津膝关节评分平均降低 35.7±8.8 比 22.4±8.5,P<0.0001;整体感知效果平均改善 91.4%比 23.9%,P<0.0001;非阿片类药物使用量的平均变化为 CRFA>IAS(P=0.02)。无与操作相关的严重不良事件。

结论

与 IAS 注射相比,本研究表明 CRFA 是一种有效且长期的治疗选择,可用于治疗疼痛和改善有疼痛性膝关节 OA 患者的身体功能和生活质量。

临床试验注册

ClinicalTrials.gov(NCT02343003)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/c752916e04ae/aap-43-84-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/d4f7ab2aabab/aap-43-84-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/20773cb34fcf/aap-43-84-g003.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/c752916e04ae/aap-43-84-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/d4f7ab2aabab/aap-43-84-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/20773cb34fcf/aap-43-84-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/23068a571e28/aap-43-84-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86e8/5768219/c752916e04ae/aap-43-84-g005.jpg

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