Brinks Aaltien, van Rijn Rogier M, Bohnen Arthur M, Slee Gabriël L J, Verhaar Jan A N, Koes Bart W, Bierma-Zeinstra Sita M A
Department of General Practice, Erasmus MC, University Medical Centre Rotterdam, the Netherlands.
BMC Musculoskelet Disord. 2007 Sep 19;8:95. doi: 10.1186/1471-2474-8-95.
Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater) trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy. This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated.
METHODS/DESIGN: This study is a pragmatic, open label randomised trial. A total of 150 patients (age 18-80 years) visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care)/(effect of injection therapy minus effect of usual care).
This study design is appropriate to estimate effectiveness and cost-effectiveness of the injection therapy. We choose to use a pragmatic study design and are thus not able to study specific effects of the injection with corticosteroids. A distinction between placebo effect of the injection and specific effects of the corticosteroids is therefore not possible.
成人髋关节局部疼痛是全科医生门诊常见的就诊原因。相当一部分患者患有（大）转子疼痛综合征或转子滑囊炎。局部皮质类固醇注射是治疗选择之一。尽管缺乏明确证据，但小型观察性研究表明，这种治疗在短期随访中有效。到目前为止，尚无随机对照试验评估注射疗法的疗效。本研究将采用随机对照试验设计，调查全科医疗中局部皮质类固醇注射治疗转子综合征的疗效。还将评估皮质类固醇注射疗法的成本效益。其次，将研究合并症与局部皮质类固醇注射疗效之间的关系。
方法/设计：本研究是一项实用的开放标签随机试验。共有150名（年龄18 - 80岁）因疑似转子疼痛综合征就诊于全科医生的患者将被分配接受局部皮质类固醇注射或接受常规护理。常规护理包括根据需要使用镇痛药。随机分组按是否合并下腰痛、髋关节骨关节炎或两者进行分层。在一年内的几个时间点通过问卷对治疗进行评估，以3个月和1年时疼痛和恢复情况的评估作为主要结局。将根据意向性治疗原则对主要和次要结局进行分析。直接和间接成本将通过问卷进行评估。成本效益将使用以下比率进行估计：成本效益比率 =（注射疗法成本减去常规护理成本）/（注射疗法效果减去常规护理效果）。
本研究设计适用于估计注射疗法的有效性和成本效益。我们选择采用实用研究设计，因此无法研究皮质类固醇注射的具体效果。因此，无法区分注射的安慰剂效应和皮质类固醇的具体效应。
