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常规(Simplicity III)和冷却(SInergy)射频用于骶髂关节去神经支配:比较两种设备的一年回顾性研究。

Conventional (Simplicity III) and Cooled (SInergy) Radiofrequency for Sacroiliac Joint Denervation: One-Year Retrospective Study Comparing Two Devices.

机构信息

Department of Anesthesiology,Intensive care and Pain Management, ASST Franciacorta, Chiari (BS), Italy.

Young Against Pain Group, Parma,Italy.

出版信息

Pain Med. 2017 Sep 1;18(9):1731-1744. doi: 10.1093/pm/pnw333.

DOI:10.1093/pm/pnw333
PMID:28340063
Abstract

OBJECTIVE

To compare two radiofrequency (RF) devices, Simplicity III (conventional RF), and SInergy (cooled RF), which are specifically designed to denervate the sacroiliac joint (SIJ).

DESIGN

Retrospective observational study.

SETTING

Italian National Health Service Public Hospital.

SUBJECTS

Forty-three patients with SIJ-derived pain refractory to conservative treatment; 21 and 22 patients, respectively, received Simplicity III or SInergy to denervate the SIJ.

METHODS

Mean numerical rating scale (NRS) and Oswestry Disability Index (ODI) scores were determined for each study group up to 12 months postprocedure. Secondary outcomes included the average amount of time required to complete each RF procedure and the adverse events associated with each technique.

RESULTS

Average SInergy group NRS and ODI scores were consistently less than those in the Simplicity III cohort at each post-RF denervation follow-up, and such differences were statistically significant at six and 12 months. The Simplicity III procedure was completed approximately 2.5 times faster than the SInergy procedure, and one minor adverse event was reported in the SInergy group.

CONCLUSIONS

The study results suggest that SInergy safely afforded patients with greater and more durable analgesia and disability relief than Simplicity III for SIJ-derived pain. The Simplicity III procedure may be more conducive than SInergy for bilateral procedures and for patients who have limited tolerance to be in an RF procedure-required prone position. Randomized controlled trials are needed to confirm the implication made in this study that SInergy is the preferred RF denervation option for treating SIJ-derived pain and the disability associated with it.

摘要

目的

比较两种射频(RF)设备,Simplicity III(常规 RF)和 SInergy(冷 RF),它们专门设计用于使骶髂关节(SIJ)去神经支配。

设计

回顾性观察研究。

地点

意大利国家卫生服务公立医院。

受试者

43 例骶髂关节源性疼痛对保守治疗无效的患者;分别有 21 例和 22 例患者接受了 Simplicity III 或 SInergy 来使 SIJ 去神经支配。

方法

对每个研究组,在术后 12 个月内测定平均数字评分量表(NRS)和 Oswestry 残疾指数(ODI)评分。次要结果包括完成每个 RF 程序所需的平均时间以及每种技术相关的不良事件。

结果

在每个 RF 去神经支配随访后,SInergy 组的平均 NRS 和 ODI 评分均始终低于 Simplicity III 组,且在 6 个月和 12 个月时差异具有统计学意义。Simplicity III 程序完成时间约为 SInergy 程序的 2.5 倍,SInergy 组报告了 1 例轻微不良事件。

结论

研究结果表明,与 Simplicity III 相比,SInergy 可更安全地为 SIJ 源性疼痛患者提供更大且更持久的镇痛和残疾缓解效果。Simplicity III 程序可能比 SInergy 更有利于双侧手术和对处于 RF 手术所需的俯卧位的耐受性有限的患者。需要进行随机对照试验来证实本研究的结论,即 SInergy 是治疗 SIJ 源性疼痛及其相关残疾的首选 RF 去神经支配选择。

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