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前瞻性自身对照研究:多齿(三叉)与传统单极套管经皮射频消融腰椎关节突关节。

Prospective Within Subject Comparison of Fluoroscopically Guided Lumbosacral Facet Joint Radiofrequency Ablation Using a Multi-Tined (Trident) Versus Conventional Monopolar Cannula.

机构信息

Vivo Cura Health, Calgary, Alberta, Canada; Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Alberta, Canada.

Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Alberta, Canada; Division of Physical Medicine and Rehabilitation, Faculty of Medicine, University of Alberta, Alberta, Canada.

出版信息

Pain Physician. 2022 Aug;25(5):391-399.

PMID:35901480
Abstract

BACKGROUND

Radiofrequency ablation (RFA) for the lumbar facet joints has demonstrated efficacy in the management of chronic low back pain. The traditional technique uses a conventional monopolar (CM) cannula placed parallel to the putative nerve to produce a thermal lesion resulting in pain relief of the facet joints. A new multi-tined (MT) cannula has come onto the market that allows targeting the putative nerve using a perpendicular to the nerve approach.

OBJECTIVES

This study describes the technique using the MT cannula and compares its efficacy and procedural characteristics to the CM cannula.

STUDY DESIGN

This is a pre-post crossover observational study.

METHODS

Fifty-one patients were recruited between June 2015 and March 2020. Each patient underwent 2 fluoroscopic guided lumbosacral RFA procedures on 2 separate occasions at the same facet joints, using the CM and MT cannula consecutively. The primary outcome measure was change in pain on the 11-point numeric rating scale (NRS). Secondary outcome measures included change in Pain Disability Quality of Life Questionnaire (PDQQ) score, duration and magnitude of pain relief, local anesthetic use, adverse events, procedural and fluoroscopy exposure time, and radiation dose.

RESULTS

There were no statistically significant difference between CM versus MT canula in terms of absolute (4.0 versus 4.3) and relative (52% versus 57%) change in NRS (P = 0.99) and PDQQ (22 versus 22, P = 0.61) at 3 months, or overall pain magnitude (71% versus 72%, P = 0.96) and duration of relief (8.7 months versus 8.4 months, P = 0.68). The procedures using the MT cannula were completed faster (37.6 minutes versus 31.1 minutes, P < 0.001) and required less local anesthetic (15.8 mL versus 11.0 mL, P < 0.001) and radiation dose (41.5 mGy versus 30.2 mGy, P = 0.05). No adverse events were observed with either cannula.

LIMITATIONS

This was an observational study at a single center with the proceduralist not blinded to the intervention.

CONCLUSION

This study demonstrated that the outcomes in terms of pain, disability, quality of life, adverse events, and fluoroscopy exposure time were equivalent between the 2 cannulae. However, RFA using the MT cannula was faster to perform and involved less local anesthetic and radiation.

摘要

背景

射频消融(RFA)治疗腰椎小关节已被证明在慢性腰痛的治疗中具有疗效。传统技术使用平行于假定神经放置的传统单极(CM)套管来产生热损伤,从而缓解小关节疼痛。一种新的多齿(MT)套管已经上市,它可以使用垂直于神经的方法来瞄准假定的神经。

目的

本研究描述了使用 MT 套管的技术,并比较了其疗效和程序特征与 CM 套管的疗效和程序特征。

研究设计

这是一项前后交叉观察性研究。

方法

2015 年 6 月至 2020 年 3 月期间,共招募了 51 名患者。每位患者在同一小关节处进行 2 次透视引导的腰骶部 RFA 操作,连续使用 CM 和 MT 套管进行。主要观察指标为数字评分量表(NRS)上疼痛的变化。次要观察指标包括疼痛残疾生活质量问卷(PDQQ)评分的变化、疼痛缓解的持续时间和程度、局部麻醉剂的使用、不良事件、手术和透视暴露时间以及辐射剂量。

结果

CM 套管与 MT 套管在 3 个月时的 NRS(4.0 与 4.3)和 PDQQ(22 与 22,P = 0.61)绝对值和相对变化(52%与 57%)方面无统计学差异,或总体疼痛程度(71%与 72%,P = 0.96)和缓解持续时间(8.7 个月与 8.4 个月,P = 0.68)。使用 MT 套管的操作完成速度更快(37.6 分钟与 31.1 分钟,P < 0.001),需要的局部麻醉剂更少(15.8 毫升与 11.0 毫升,P < 0.001),辐射剂量也更低(41.5 毫戈瑞与 30.2 毫戈瑞,P = 0.05)。两种套管均未观察到不良事件。

局限性

这是一项单中心观察性研究,手术医生对干预措施没有盲法。

结论

本研究表明,两种套管的疼痛、残疾、生活质量、不良事件和透视暴露时间结果相当。然而,使用 MT 套管进行 RFA 操作速度更快,使用的局部麻醉剂和辐射量更少。

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