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Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial
Annals of the Rheumatic Diseases ( IF 20.3 ) Pub Date : 2018-03-07 , DOI: 10.1136/annrheumdis-2017-212628
Desirée M J Dorleijn , Pim A J Luijsterburg , Max Reijman , Margreet Kloppenburg , Jan A N Verhaar , Patrick J E Bindels , Pieter Koen Bos , Sita M A Bierma-Zeinstra

Objectives Guidelines recommend intra-articular glucocorticoid injection in patients with painful hip osteoarthritis. However, intra-articular hip injection is an invasive procedure. The efficacy of systemic glucocorticoid treatment for pain reduction in hip osteoarthritis is unknown. This randomised, double-blind, trial assessed effectiveness in hip pain reduction of an intramuscular glucocorticoid injection compared with a placebo injection in patients with hip osteoarthritis. Methods Patients with painful hip osteoarthritis were randomised to either 40 mg triamcinolone acetate or placebo with an intramuscular injection into the gluteus muscle. The primary outcomes were severity of hip pain at rest, during walking (0–10) and WOMAC pain at 2-week postinjection. We used linear mixed models for repeated measurements at 2, 4, 6 and 12 weeks for the intention-to-treat data analysis. Results Of the 107 patients randomised, 106 could be analysed (52 in the glucocorticoid group, 54 in the placebo group). At 2-week follow-up, compared with placebo injection, the intramuscular glucocorticoid injection showed a significant and clinically relevant difference in hip pain reduction at rest (difference −1.3, 95% CI −2.3 to −0.3). This effect persisted for the entire 12-week follow-up. For hip pain during walking, the effect was present at 4-week, 6-week and 12-week follow-ups, and for WOMAC pain the effect was present at 6-week and 12-week follow-up. Conclusions An intramuscular glucocorticoid injection showed effectiveness in patients with hip osteoarthritis on one of the three primary outcomes at 2-week postinjection. All primary outcomes showed effectiveness from 4 to 6 weeks, up to a 12-week follow-up. Trial registration number NTR2966.

中文翻译:

肌内糖皮质激素注射与安慰剂注射治疗髋骨关节炎:一项为期 12 周的盲法随机对照试验

目的 指南推荐对疼痛性髋骨关节炎患者进行关节内糖皮质激素注射。然而,关节内髋关节注射是一种侵入性手术。全身性糖皮质激素治疗减轻髋骨关节炎疼痛的疗效尚不清楚。这项随机、双盲试验评估了肌内糖皮质激素注射与安慰剂注射相比在髋骨关节炎患者中减轻髋部疼痛的有效性。方法 患有疼痛性髋骨关节炎的患者被随机分配至 40 mg 醋酸曲安奈德或安慰剂并肌肉注射到臀肌。主要结果是休息时、行走时 (0-10) 时髋部疼痛的严重程度以及注射后 2 周时的 WOMAC 疼痛。我们使用线性混合模型在 2、4、6 周和 12 周进行意向治疗数据分析。结果 在随机分组的 107 名患者中,可以分析 106 名(糖皮质激素组 52 名,安慰剂组 54 名)。在 2 周的随访中,与安慰剂注射相比,肌肉注射糖皮质激素在静息时髋关节疼痛减轻方面表现出显着的临床相关差异(差异 -1.3,95% CI -2.3 至 -0.3)。这种影响在整个 12 周的随访中持续存在。对于行走时的髋部疼痛,效果在 4 周、6 周和 12 周的随访中出现,而对于 WOMAC 疼痛,效果在 6 周和 12 周的随访中出现。结论肌内糖皮质激素注射对髋骨关节炎患者在注射后 2 周的三个主要结果之一中显示出有效性。所有主要结果均显示 4 至 6 周的有效性,长达 12 周的随访。试用注册号 NTR2966。
更新日期:2018-03-07
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