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聚焦式冲击波治疗转子间区疼痛综合征:一项多中心、随机、对照临床试验。

Focused Shockwave Treatment for Greater Trochanteric Pain Syndrome: A Multicenter, Randomized, Controlled Clinical Trial.

机构信息

Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.

Garcia Cugat Foundation-CEU, Barcelona, Spain.

出版信息

J Bone Joint Surg Am. 2020 Aug 5;102(15):1305-1311. doi: 10.2106/JBJS.20.00093.

Abstract

BACKGROUND

Greater trochanteric pain syndrome (GTPS) is a condition of lateral hip pain. Its physiopathology remains unknown, and there is no consensus on optimal management. The aim of this study was to assess the effectiveness of electromagnetic-focused extracorporeal shockwave treatment (F-ESWT) in patients with GTPS.

METHODS

This multicenter clinical trial included 103 patients with chronic GTPS randomly assigned to the treatment group, consisting of electromagnetic F-ESWT and a specific exercise protocol, or the control group, receiving sham F-ESWT and the same exercise protocol. Both groups were treated with 3 weekly sessions; the F-ESWT group received an energy flux density of 0.20 mJ/mm, whereas the control group received 0.01 mJ/mm. Patients were assessed at baseline and 1, 2, 3, and 6 months after treatment. A visual analogue scale (VAS) score for pain at 2 months was the primary outcome. The Harris hip score (HHS), Lower Extremity Functional Scale (LEFS), EuroQoL-5 Dimensions Questionnaire (EQ-5D), and Roles and Maudsley score were used as secondary outcomes. Complications were recorded.

RESULTS

The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001). All secondary outcomes at all follow-up intervals were significantly better in the F-ESWT group, except for the LEFS score at 1 month after treatment (p = 0.25). No complications were observed.

CONCLUSIONS

F-ESWT in association with a specific exercise program is safe and effective for GTPS, with a success rate of 86.8% at 2 months after treatment, which was maintained until the end of follow-up.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

大转子疼痛综合征(GTPS)是一种髋关节外侧疼痛的病症。其病理生理学仍不清楚,也没有关于最佳治疗方法的共识。本研究旨在评估电磁聚焦体外冲击波治疗(F-ESWT)对 GTPS 患者的疗效。

方法

这项多中心临床试验纳入了 103 例慢性 GTPS 患者,随机分为治疗组(电磁 F-ESWT 加特定运动方案)和对照组(假 F-ESWT 加相同运动方案)。两组均每周治疗 3 次,F-ESWT 组的能量通量密度为 0.20 mJ/mm,对照组为 0.01 mJ/mm。患者在基线时和治疗后 1、2、3 和 6 个月进行评估。2 个月时的视觉模拟评分(VAS)疼痛评分是主要结局。Harris 髋关节评分(HHS)、下肢功能量表(LEFS)、欧洲五维健康量表(EQ-5D)和 Roles 和 Maudsley 评分作为次要结局。记录并发症。

结果

两组的 VAS 评分均从基线时的 6.3 分降至治疗后 2 个月时的 2.0 分(F-ESWT 组)和 4.7 分(对照组),2 个月时两组间的评分差异有统计学意义(p < 0.001)。除治疗后 1 个月的 LEFS 评分(p = 0.25)外,所有随访时间点的其他次要结局在 F-ESWT 组均显著更好。未观察到并发症。

结论

F-ESWT 联合特定运动方案治疗 GTPS 安全有效,治疗后 2 个月的成功率为 86.8%,直至随访结束。

证据水平

治疗性 I 级。有关证据水平的完整描述,请参阅作者指南。

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