School of Health and Rehabilitation Sciences, University of Queensland, QLD 4072, Australia.
Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, Carlton, VIC, Australia.
BMJ. 2018 May 2;361:k1662. doi: 10.1136/bmj.k1662.
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.
Prospective, three arm, single blinded, randomised clinical trial.
Brisbane and Melbourne, Australia.
Individuals aged 35-70 years, with lateral hip pain for more than three months, at least 4/10 on the pain numerical rating scale, and gluteal tendinopathy confirmed by clinical diagnosis and magnetic resonance imaging; and with no corticosteroid injection use in previous 12 months, current physiotherapy, total hip replacement, or neurological conditions.
A physiotherapy led education and exercise programme of 14 sessions over eight weeks (EDX; n=69), one corticosteroid injection (CSI; n=66), and a wait and see approach (WS; n=69).
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 eight weeks, with longer term follow-up at 52 weeks.
Of 204 randomised participants (including 167 women; mean age 54.8 years (standard deviation 8.8)), 189 (92.6%) completed 52 week follow-up. Success on the global rating of change was reported at eight 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% confidence interval 34.6% to 63.5%), number needed to treat 2.0 (95% confidence interval 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 eight weeks, reported pain on the numerical rating scale was mean score 1.5 (standard deviation 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% confidence interval -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).
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.
Prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN12612001126808).
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。
前瞻性、三臂、单盲、随机临床试验。
澳大利亚布里斯班和墨尔本。
年龄 35-70 岁,有至少 3 个月的髋外侧疼痛,疼痛数字评分量表(numerical rating scale,NRS)评分至少为 4/10,且经临床诊断和磁共振成像(magnetic resonance imaging,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、全髋关节置换或患有神经疾病。
一项由物理治疗师主导的 14 次 8 周教育和运动计划(EDX;n=69)、单次皮质类固醇注射(CSI;n=66)和等待观察方法(WS;n=69)。
主要结局是患者报告的髋关节状况整体改善的全球评分(11 分制,分为成功和不成功)和过去一周的疼痛强度(0 表示无痛,10 表示最痛),并在 52 周时进行了更长时间的随访。
204 名随机参与者(包括 167 名女性;平均年龄 54.8 岁(标准差 8.8))中,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 名参与者报告全球改善评分成功。EDX 和 CSI 的全球改善评分优于 WS(风险差异 49.1%(95%置信区间 34.6%至 63.5%),需要治疗的人数 2.0(95%置信区间 1.6 至 2.9);29.2%(13.2%至 45.2%),3.4(2.2 至 7.6);分别)。EDX 的全球改善评分优于 CSI(19.9%(4.7%至 35.0%),5.0(2.9 至 21.1%))。在 8 周时,EDX、CSI 和 WS 组报告的 NRS 疼痛平均评分分别为 1.5(标准差 1.5)、2.7(2.4)和 3.8(2.0)。EDX 和 CSI 组报告的疼痛少于 WS 组(平均差异-2.2(95%置信区间-2.89 至-1.54);-1.2(-1.85 至-0.50);分别),EDX 组报告的疼痛少于 CSI 组(-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 名参与者报告全球改善评分成功;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 组报告的 NRS 疼痛平均评分分别为 2.1(2.2)、2.3(1.9)和 3.2(2.6);EDX 与 CSI 无差异(-0.26(-1.06 至-0.55)),但两种治疗均优于 WS(1.13(-1.93 至-0.33);0.87(-1.68 至-0.07);分别)。
对于臀肌腱病,教育加运动和皮质类固醇注射使用在 8 周时比不治疗导致更高的患者报告的全球改善率和更低的疼痛强度。教育加运动优于皮质类固醇注射使用。在 52 周随访时,教育加运动导致的全球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。
前瞻性注册于澳大利亚新西兰临床试验注册中心(ACTRN12612001126808)。