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双相与单相关节内脉冲射频热凝术治疗慢性膝关节疼痛的前瞻性随机试验

Bipolar Versus Unipolar Intraarticular Pulsed Radiofrequency Thermocoagulation in Chronic Knee Pain Treatment: A Prospective Randomized Trial.

作者信息

Gulec Ersel, Ozbek Hayri, Pektas Sinan, Isik Geylan

机构信息

Department of Anesthesiology and Pain Medicine, Cukurova University Faculty of Medicine, Adana, Turkey.

出版信息

Pain Physician. 2017 Mar;20(3):197-206.

PMID:28339432
Abstract

BACKGROUND

Chronic knee pain is a major widespread problem causing significant impairment of daily function. Pulsed radiofrequency has been shown to reduce severe chronic joint pain as a non-pharmacological and less invasive treatment method.

OBJECTIVE

We aimed to compare the effectiveness of unipolar and bipolar intraarticular pulsed radiofrequency methods in chronic knee pain control.

STUDY DESIGN

Prospective, randomized, double-blind study.

SETTING

Pain clinic in Cukurova University Faculty of Medicine.

METHODS

One hundred patients, aged 20 - 70 years with grade 2 or 3 knee osteoarthritis were included in this study. Patients were randomly allocated into 2 groups to receive either unipolar (group U, n = 50) or bipolar (group B, n = 50) intraarticular pulsed radiofrequency (IAPRF) with a 45 V voltage, 2 Hz frequency, 42° C temperature, 10 msec pulse width, and 10 minute duration. We recorded visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index LK 3.1WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index LK 3.1) scores of patients at baseline and one, 4, and 12 weeks after the procedure. The primary outcome was the percentage of patients with ≥ 50% reduction in knee pain at 12 weeks after the procedure.

RESULTS

There was a significant difference between the groups according to VAS scores at all post-intervention time points. In group B, 84% of patients, and in the group U, 50% of patients achieved at least 50% knee pain relief from the baseline to 3 months. In group B, WOMAC scores were significantly lower than the group U at one and 3 months.

LIMITATIONS

Lack of long-term clinical results and supportive laboratory tests.

CONCLUSION

Bipolar IAPRF is more advantageous in reducing chronic knee pain and functional recovery compared with unipolar IAPRF. Further studies with longer follow-up times, laboratory-based tests, and different generator settings are required to establish the clinical importance and well-defined mechanism of action of PRF. This study protocol was registered at clinicaltrials.gov (identifier: NCT02141529), on May 15, 2014. Institutional Review Board (IRB) approval date: January 16, 2014, and number: 26/9Key words: Chronic pain, intraarticular, knee joint, knee osteoarthritis, pain management, pulsed radiofrequency treatment, quality of life, recovery of function.

摘要

背景

慢性膝关节疼痛是一个广泛存在的主要问题,会严重损害日常功能。脉冲射频已被证明作为一种非药物且侵入性较小的治疗方法,可减轻严重的慢性关节疼痛。

目的

我们旨在比较单极和双极关节内脉冲射频方法在控制慢性膝关节疼痛方面的有效性。

研究设计

前瞻性、随机、双盲研究。

研究地点

库库洛瓦大学医学院疼痛诊所。

方法

本研究纳入了100例年龄在20 - 70岁、患有2级或3级膝关节骨关节炎的患者。患者被随机分为两组,分别接受单极(U组,n = 50)或双极(B组,n = 50)关节内脉冲射频(IAPRF)治疗,电压为45V,频率为2Hz,温度为42°C,脉冲宽度为10毫秒,持续时间为10分钟。我们记录了患者在基线以及治疗后1周、4周和12周时的视觉模拟量表(VAS)评分和西安大略和麦克马斯特大学骨关节炎指数LK 3.1(WOMAC)评分。主要结局是治疗后12周膝关节疼痛减轻≥50%的患者百分比。

结果

在所有干预后时间点,两组间VAS评分存在显著差异。在B组中,84%的患者,在U组中,50%的患者从基线到3个月时膝关节疼痛至少减轻了50%。在B组中,1个月和3个月时WOMAC评分显著低于U组。

局限性

缺乏长期临床结果和支持性实验室检查。

结论

与单极IAPRF相比,双极IAPRF在减轻慢性膝关节疼痛和功能恢复方面更具优势。需要进行更长随访时间、基于实验室的检查以及不同发生器设置的进一步研究,以确定PRF的临床重要性和明确的作用机制。本研究方案于2014年5月15日在clinicaltrials.gov(标识符:NCT02141529)注册。机构审查委员会(IRB)批准日期:2014年1月16日,编号:26/9关键词:慢性疼痛、关节内、膝关节、膝关节骨关节炎、疼痛管理、脉冲射频治疗、生活质量功能恢复。

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