肌肉内皮质类固醇注射与安慰剂注射治疗髋骨关节炎患者的疗效比较：一项随机双盲对照试验的设计。
Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial.
机构信息
Department of General Practice, Erasmus MC, University Medical Center, Rotterdam, Rotterdam, The Netherlands.
出版信息
BMC Musculoskelet Disord. 2011 Dec 12;12:280. doi: 10.1186/1471-2474-12-280.
BACKGROUND
Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed.The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication.
METHODS/DESIGN: This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years) with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline) injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics). Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle.
DISCUSSION
This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started.
TRIAL REGISTRATION
This trial is registered in the Dutch Trial Registry: number NTR2966.
背景
最近的国际指南建议对髋骨关节炎患者进行关节内皮质类固醇注射，这些患者有中度至重度疼痛，且对口服镇痛/抗炎药物反应不佳。在五项可用的随机对照试验中，四项显示出在减轻疼痛方面的积极效果。然而，髋关节内注射非常复杂，因为关节毗邻重要的神经血管结构，无法触诊。因此需要进行荧光透视或超声引导。皮质类固醇的全身作用已在撞击肩痛患者中进行了研究。臀肌皮质类固醇注射与超声引导下肩峰下皮质类固醇注射几乎同样有效。对于对口服止痛药无反应的髋骨关节炎患者，这种皮质类固醇全身注射的临床相关效果提供了一种更简单的替代治疗方法。
方法/设计：这是一项双盲、随机对照试验。共纳入 135 名（年龄>40 岁）髋骨关节炎患者，这些患者在接受全科医生或矫形外科医生治疗时，尽管服用了口服止痛药，但仍持续疼痛。他们将被随机分配接受臀肌内皮质类固醇注射或臀肌内安慰剂（生理盐水）注射。随机分组将根据治疗场所（全科医生和矫形外科门诊）进行分层。治疗效果将通过患者在 2、4、6 和 12 周随访时的问卷调查以及 12 周时的体格检查进行评估。主要结局是患者在 2 周随访时报告的髋部疼痛严重程度。统计分析将基于意向治疗原则进行。
讨论
本研究将评估肌肉内皮质类固醇注射对髋骨关节炎患者疼痛的有效性。患者招募已开始。
试验注册
本试验已在荷兰试验注册中心注册：编号 NTR2966。
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