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教育加运动与皮质类固醇注射治疗与等待观察对臀肌腱病的整体疗效和疼痛的影响:前瞻性、单盲、随机临床试验。

Education plus exercise versus corticosteroid injection use versus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomised clinical trial.

机构信息

School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Queensland, Australia.

Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, Carlton, Victoria, Australia.

出版信息

Br J Sports Med. 2018 Nov;52(22):1464-1472. doi: 10.1136/bjsports-2018-k1662rep.

DOI:10.1136/bjsports-2018-k1662rep
PMID:30385462
Abstract

OBJECTIVE

To compare the effects of a programme of load management education plus exercise, corticosteroid injection use, and no treatment on pain and global improvement in individuals with gluteal tendinopathy.

DESIGN

Prospective, three arm, single blinded, randomised clinical trial.

SETTING

Brisbane and Melbourne, Australia.

PARTICIPANTS

Individuals aged 35-70 years, with lateral hip pain for more than 3 months, at least 4/10 on the pain numerical rating scale, and gluteal tendinopathy confirmed by clinical diagnosis and MRI; and with no corticosteroid injection use in previous 12 months, current physiotherapy, total hip replacement, or neurological conditions.

INTERVENTIONS

A physiotherapy led education and exercise programme of 14 sessions over 8 weeks (EDX; n=69), one corticosteroid injection (CSI; n=66), and a wait and see approach (WS; n=69).

MAIN OUTCOMES

Primary outcomes were patient reported global rating of change in hip condition (on an 11 point scale, dichotomised to success and non-success) and pain intensity in the past week (0=no pain, 10=worst pain) at 8 weeks, with longer term follow-up at 52 weeks.

RESULTS

Of 204 randomised participants (including 167 women; mean age 54.8 years (SD 8.8)), 189 (92.6%) completed 52 week follow-up. Success on the global rating of change was reported at 8 weeks by 51/66 EDX, 38/65 CSI, and 20/68 WS participants. EDX and CSI had better global improvement scores than WS (risk difference 49.1% (95% CI 34.6% to 63.5%), number needed to treat 2.0 (95% CI 1.6 to 2.9); 29.2% (13.2% to 45.2%), 3.4 (2.2 to 7.6); respectively). EDX had better global improvement scores than CSI (19.9% (4.7% to 35.0%); 5.0 (2.9 to 21.1)). At 8 weeks, reported pain on the numerical rating scale was mean score 1.5 (SD 1.5) for EDX, 2.7 (2.4) for CSI, and 3.8 (2.0) for WS. EDX and CSI participants reported less pain than WS (mean difference -2.2 (95% CI -2.89 to -1.54); -1.2 (-1.85 to -0.50); respectively), and EDX participants reported less pain than CSI (-1.04 (-1.72 to -0.37)). Success on the global rating of change was reported at 52 weeks by 51/65 EDX, 36/63 CSI, and 31/60 WS participants; EDX was better than CSI (20.4% (4.9% to 35.9%); 4.9 (2.8 to 20.6)) and WS (26.8% (11.3% to 42.3%); 3.7 (2.4 to 8.8)). Reported pain at 52 weeks was 2.1 (2.2) for EDX, 2.3 (1.9) for CSI, and 3.2 (2.6) for WS; EDX did not differ from CSI (-0.26 (-1.06 to 0.55)), but both treatments did better than WS (1.13 (-1.93 to -0.33); 0.87 (-1.68 to -0.07); respectively).

CONCLUSIONS

For gluteal tendinopathy, education plus exercise and corticosteroid injection use resulted in higher rates of patient reported global improvement and lower pain intensity than no treatment at eight weeks. Education plus exercise performed better than corticosteroid injection use. At 52 week follow-up, education plus exercise led to better global improvement than corticosteroid injection use, but no difference in pain intensity. These results support EDX as an effective management approach for gluteal tendinopathy.

TRIAL REGISTRATION NUMBER

Prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN12612001126808).

摘要

目的

比较负荷管理教育加运动、皮质类固醇注射使用和不治疗对臀肌腱病患者疼痛和整体改善的效果。

设计

前瞻性、三臂、单盲、随机临床试验。

地点

澳大利亚布里斯班和墨尔本。

参与者

年龄 35-70 岁,有外侧髋关节疼痛超过 3 个月,疼痛数字评分量表至少为 4/10,且经临床诊断和 MRI 证实为臀肌腱病;在过去 12 个月内未使用皮质类固醇注射、当前接受物理治疗、全髋关节置换或有神经疾病。

干预措施

一项由物理治疗师主导的 14 次 8 周的教育和运动计划(EDX;n=69),一次皮质类固醇注射(CSI;n=66),以及等待观察方法(WS;n=69)。

主要结局

主要结局是患者报告的髋关节状况整体改善评分(11 分制,分为成功和不成功)和过去一周的疼痛强度(0 表示无疼痛,10 表示最疼痛),8 周时进行随访,52 周时进行长期随访。

结果

在 204 名随机参与者中(包括 167 名女性;平均年龄 54.8 岁(SD 8.8)),189 名(92.6%)完成了 52 周随访。在 8 周时,EDX、CSI 和 WS 组分别有 51/66、38/65 和 20/68 名患者报告整体改善评分成功。EDX 和 CSI 的整体改善评分优于 WS(风险差异 49.1%(95%CI 34.6%至 63.5%),需要治疗的人数 2.0(95%CI 1.6 至 2.9);29.2%(13.2%至 45.2%),3.4(2.2 至 7.6);分别)。EDX 的整体改善评分优于 CSI(19.9%(4.7%至 35.0%),5.0(2.9 至 21.1))。在 8 周时,EDX、CSI 和 WS 组的数字评分量表报告疼痛的平均评分分别为 1.5(SD 1.5)、2.7(2.4)和 3.8(2.0)。EDX 和 CSI 组报告的疼痛比 WS 组少(平均差异-2.2(95%CI-2.89 至-1.54);-1.2(-1.85 至-0.50);分别),EDX 组报告的疼痛比 CSI 组少(-1.04(-1.72 至-0.37))。在 52 周时,EDX、CSI 和 WS 组分别有 51/65、36/63 和 31/60 名患者报告整体改善评分成功;EDX 优于 CSI(20.4%(4.9%至 35.9%),4.9(2.8 至 20.6))和 WS(26.8%(11.3%至 42.3%),3.7(2.4 至 8.8))。在 52 周时,EDX、CSI 和 WS 组的报告疼痛分别为 2.1(2.2)、2.3(1.9)和 3.2(2.6);EDX 与 CSI 之间无差异(-0.26(-1.06 至-0.55)),但两种治疗方法均优于 WS(1.13(-1.93 至-0.33);0.87(-1.68 至-0.07);分别)。

结论

对于臀肌腱病,教育加运动和皮质类固醇注射使用比不治疗在 8 周时能更有效地提高患者报告的整体改善率和降低疼痛强度。教育加运动优于皮质类固醇注射使用。在 52 周随访时,教育加运动导致的整体改善优于皮质类固醇注射使用,但疼痛强度无差异。这些结果支持 EDX 作为臀肌腱病的有效管理方法。

试验注册

前瞻性在澳大利亚和新西兰临床试验注册中心(ACTRN12612001126808)注册。

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