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教育、夜间夹板固定和运动与常规护理对等待腕管手术患者恢复及手术转化率的影响:一项随机对照试验方案

Education, night splinting and exercise versus usual care on recovery and conversion to surgery for people awaiting carpal tunnel surgery: a protocol for a randomised controlled trial.

作者信息

Lewis Karina J, Ross Leo, Coppieters Michel W, Vicenzino Bill, Schmid Annina B

机构信息

Occupational Therapy Department, Gold Coast University Hospital, Queensland, Australia School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.

Occupational Therapy Department, Gold Coast University Hospital, Queensland, Australia.

出版信息

BMJ Open. 2016 Sep 16;6(9):e012053. doi: 10.1136/bmjopen-2016-012053.

Abstract

INTRODUCTION

Carpal tunnel syndrome (CTS) is a prevalent upper limb condition that results in significant individual and socioeconomic costs. Large patient numbers, long outpatient waiting times and traditional referral pathways in public health systems create delays in accessing treatment for this condition. Alternative care pathways aimed at streamlining access to treatment and reducing the need for surgical intervention warrant further investigation.

METHODS

A randomised, single-blind controlled clinical trial will be conducted. 128 participants aged 18-75 years with CTS will be recruited from the carpal tunnel surgery waitlists of participating public hospitals. Suitable participants will be stratified for severity and randomly allocated to either receive therapy (education, provision of splints and a home exercise programme) or standard care (continuing on the waitlist without hand therapy intervention for the duration of the study). Outcomes will be measured at baseline and after 6 weeks and 6 months. Primary outcomes are conversion to surgery ratio and perceived effect via the Global Rating of Change Scale.Secondary measures include patient satisfaction, and monitoring of symptoms and function using outcome measures including the Boston CTS Questionnaire, Disability of Arm, Shoulder and Hand Questionnaire, Patient-Specific Functional Scale, patient completed diagram of symptoms and Self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale.

DISCUSSION

This paper outlines the design and rationale for a randomised controlled trial that aims to assess the efficacy of an alternative care pathway for the management of patients with CTS while on the surgery waitlist. It is anticipated that the outcomes of this study will contribute to improved and expedited management of this common condition in a public hospital setting.

ETHICS AND DISSEMINATION

Ethics approval was granted by the Princess Alexandra Hospital Centres for Health Research (HREC/13/QPAH/434-SSA/13/QPAH/447) and the Medical Research Ethics Committee at the University of Queensland. Results will be disseminated via conferences and peer-reviewed publications.

TRIAL REGISTRATION NUMBER

ACTRN12613001095752.

摘要

引言

腕管综合征(CTS)是一种常见的上肢疾病,会给个人和社会经济带来巨大成本。公共卫生系统中患者数量众多、门诊等待时间长以及传统的转诊途径导致了这种疾病治疗的延误。旨在简化治疗途径并减少手术干预需求的替代护理途径值得进一步研究。

方法

将进行一项随机、单盲对照临床试验。从参与研究的公立医院腕管手术等候名单中招募128名年龄在18至75岁之间的CTS患者。合适的参与者将根据病情严重程度分层,并随机分配接受治疗(教育、提供夹板和家庭锻炼计划)或标准护理(在研究期间继续留在等候名单上,不接受手部治疗干预)。将在基线、6周和6个月后测量结果。主要结果是手术转化率和通过总体变化量表感知到的效果。次要测量指标包括患者满意度,以及使用包括波士顿CTS问卷、手臂、肩部和手部功能障碍问卷、患者特定功能量表、患者完成的症状图和自我报告的利兹神经病变症状和体征疼痛量表等结果测量指标对症状和功能进行监测。

讨论

本文概述了一项随机对照试验的设计和原理,该试验旨在评估在手术等候名单上的CT管理障碍问卷、患者特定功能量表、患者完成的症状图和自我报告的利兹神经病变症状和体征疼痛量表等结果测量指标对症状和功能进行监测。

讨论

本文概述了一项随机对照试验的设计和原理,该试验旨在评估在手术等候名单上对CTS患者进行管理的替代护理途径的疗效。预计本研究的结果将有助于在公立医院环境中改善和加快对这种常见疾病的管理。

伦理与传播

亚历山德拉公主医院健康研究中心(HREC/13/QPAH/434 - SSA/13/QPAH/447)和昆士兰大学医学研究伦理委员会已批准伦理许可。研究结果将通过会议和同行评审出版物进行传播。

试验注册号

ACTRN12613001095752。

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