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干针疗法与皮质类固醇注射治疗大转子疼痛综合征的非劣效性随机临床试验

Dry Needling Versus Cortisone Injection in the Treatment of Greater Trochanteric Pain Syndrome: A Noninferiority Randomized Clinical Trial.

作者信息

Brennan Kindyle L, Allen Bryce C, Maldonado Yolanda Munoz

出版信息

J Orthop Sports Phys Ther. 2017 Apr;47(4):232-239. doi: 10.2519/jospt.2017.6994. Epub 2017 Mar 3.

Abstract

Study Design Prospective, randomized, partially blinded. Background Greater trochanteric pain syndrome (GTPS) is the current terminology for what was once called greater trochanteric or subgluteal bursitis. Cortisone (corticosteroid) injection into the lateral hip has traditionally been the accepted treatment for this condition; however, the effectiveness of injecting the bursa with steroids is increasingly being questioned. An equally effective treatment with fewer adverse side effects would be beneficial. Objective To investigate whether administration of dry needling (DN) is noninferior to cortisone injection in reducing lateral hip pain and improving function in patients with GTPS. Methods Forty-three participants (50 hips observed), all with GTPS, were randomly assigned to a group receiving cortisone injection or DN. Treatments were administered over 6 weeks, and clinical outcomes were collected at baseline and at 1, 3, and 6 weeks. The primary outcome measure was the numeric pain-rating scale (0-10). The secondary outcome measure was the Patient-Specific Functional Scale (0-10). Medication intake for pain was collected as a tertiary outcome. Results Baseline characteristics were similar between groups. A noninferiority test for a repeated-measures design for pain and averaged function scores at 6 weeks (with a noninferiority margin of 1.5 for both outcomes) indicated noninferiority of DN versus cortisone injection (both, P<.01). Medication usage (P = .74) was not different between groups at the same time point. No adverse side effects were reported. Conclusion Cortisone injections for GTPS did not provide greater pain relief or reduction in functional limitations than DN. Our data suggest that DN is a noninferior treatment alternative to cortisone injections in this patient population. Level of Evidence Therapy, level 1b. Registered December 2, 2015 at www.clinicaltrials.gov (NCT02639039). J Orthop Sports Phys Ther 2017;47(4):232-239. Epub 3 Mar 2017. doi:10.2519/jospt.2017.6994.

摘要

研究设计

前瞻性、随机、部分盲法。背景:大转子疼痛综合征(GTPS)是曾被称为大转子或臀下滑囊炎的当前术语。传统上,向髋关节外侧注射可的松(皮质类固醇)一直是这种病症的公认治疗方法;然而,向滑囊注射类固醇的有效性越来越受到质疑。一种具有更少不良副作用的同等有效治疗方法将是有益的。目的:研究在减轻GTPS患者的髋关节外侧疼痛和改善功能方面,干针疗法(DN)是否不劣于可的松注射。方法:43名参与者(观察50个髋关节),均患有GTPS,被随机分配到接受可的松注射或DN的组。治疗持续6周,在基线以及第1、3和6周收集临床结果。主要结局指标是数字疼痛评分量表(0 - 10)。次要结局指标是患者特定功能量表(0 - 10)。收集疼痛药物摄入量作为第三结局指标。结果:两组之间的基线特征相似。对疼痛和6周时平均功能评分的重复测量设计进行非劣效性检验(两个结局的非劣效性界值均为1.5)表明,DN相对于可的松注射不劣(两者,P <.01)。在同一时间点,两组之间的药物使用情况(P =.74)没有差异。未报告不良副作用。结论:对于GTPS,可的松注射在减轻疼痛或减少功能受限方面并不比DN更有效。我们的数据表明,在该患者群体中,DN是可的松注射的非劣效治疗替代方法。证据级别:治疗,1b级。于2015年12月2日在www.clinicaltrials.gov注册(NCT02639039)。《矫形与运动物理治疗杂志》2017年;47(4):232 - 239。2017年3月3日在线发表。doi:10.2519/jospt.2017.6994

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