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超声成像指导急性肩痛的治疗:一项全科医疗中的随机对照试验

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice.

作者信息

Ottenheijm Ramon P G, Cals Jochen W L, Winkens Bjorn, Weijers René E, de Bie Rob A, Dinant Geert-Jan

机构信息

Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.

Department of Methodology and Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.

出版信息

BMJ Open. 2016 Nov 21;6(11):e011048. doi: 10.1136/bmjopen-2016-011048.

Abstract

OBJECTIVE

To determine the clinical effectiveness of ultrasound tailored treatment in patients with acute subacromial disorders.

DESIGN

Pragmatic randomised controlled trial.

SETTING

Dutch general practice.

PARTICIPANTS

Patients aged 18-65 years with acute (duration <3 months) unilateral shoulder pain and no previous treatment, in whom the general practitioner suspected a subacromial disorder was enrolled.

INTERVENTIONS

All patients underwent ultrasound imaging of the affected shoulder. Patients who were still symptomatic after a qualification period of 2 weeks with standard treatment were randomised to treatment tailored to ultrasound diagnosis (disclosure of the ultrasound diagnosis) or usual care (non-disclosure of the ultrasound diagnosis).

PRIMARY OUTCOME MEASURE

Patient-perceived recovery using the Global Perceived Effect questionnaire at 1 year.

RESULTS

129 patients were included. 18 patients recovered during the 2-week qualification period, resulting in 111 randomised patients; 56 were allocated to ultrasound tailored treatment and 55 to usual care. After 1 year, no statistically significant differences in recovery were found between the ultrasound tailored treatment group (72.5% (37/51)) and the usual care group (60% (30/50), OR 2.24 (95% CI 0.72 to 6.89; p=0.16)). Also, healthcare use was similar.

CONCLUSIONS

This study has shown no clinically significant difference in the primary outcome measure between the ultrasound tailored treatment and usual care groups. Furthermore, there was no overall difference in healthcare resources used between groups. Although no formal cost data are included, one can only assume that the ultrasound examinations are additional costs for the intervention group, which cannot be justified in routine practice based on this trial. Based on this study, no change in current pragmatic guidelines to incorporate early ultrasound imaging can be recommended.

TRIAL REGISTRATION NUMBER

NTR2403; Results.

摘要

目的

确定超声定制治疗对急性肩峰下疾病患者的临床疗效。

设计

实用随机对照试验。

地点

荷兰全科医疗。

参与者

年龄在18 - 65岁之间、患有急性(病程<3个月)单侧肩部疼痛且此前未接受过治疗、全科医生怀疑患有肩峰下疾病的患者。

干预措施

所有患者均接受患侧肩部的超声检查。经过2周标准治疗后仍有症状的患者被随机分为超声诊断定制治疗组(告知超声诊断结果)或常规治疗组(不告知超声诊断结果)。

主要结局指标

使用全球感知效应问卷评估患者在1年时自我感知的恢复情况。

结果

纳入129例患者。18例患者在2周的资格期内康复,因此有111例患者被随机分组;56例被分配至超声定制治疗组,55例被分配至常规治疗组。1年后,超声定制治疗组(72.5%(37/51))和常规治疗组(60%(30/50),比值比2.24(95%可信区间0.72至6.89;p = 0.16))在恢复情况上未发现统计学显著差异。此外,医疗保健利用情况相似。

结论

本研究表明,超声定制治疗组和常规治疗组在主要结局指标上无临床显著差异。此外,两组之间在医疗资源使用方面无总体差异。尽管未纳入正式的成本数据,但只能推测超声检查对干预组来说是额外费用,基于该试验,在常规实践中无法证明其合理性。基于本研究,不建议对当前实用指南进行改变以纳入早期超声成像。

试验注册号

NTR2403;结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/919f/5128954/51402900813e/bmjopen2016011048f01.jpg

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