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肩部撞击综合征(SIS)手术后远程康复计划的有效性:一项随机对照非劣效性试验的研究方案

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

作者信息

Pastora-Bernal Jose-Manuel, Martín-Valero Rocío, Barón-López Francisco Javier, García-Gómez Oscar

机构信息

Health Science, Degree of Physiotherapy, University of Málaga, Málaga, Spain.

Department of Physiotherapy, Faculty of Health Sciences C/Arquitecto Francisco Peñalosa Ampliación del C. Teatinos, 29071, Málaga, Spain.

出版信息

Trials. 2017 Feb 23;18(1):82. doi: 10.1186/s13063-017-1822-x.

Abstract

BACKGROUND

Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery.

METHODS

We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design.

DISCUSSION

Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02909920 . 14 September 2016.

摘要

背景

肩痛在社会中很常见,在普通人群中患病率很高。肩峰撞击综合征(SIS)是最常见的病因。患者在受影响的关节处会遭受疼痛、肌肉无力和活动受限。初始治疗主要是保守治疗。手术治疗成功率高,通常在保守治疗失败时使用。为恢复关节活动范围、肌肉力量、稳定性和功能,需要进行传统物理治疗和术后锻炼。远程康复计划在一些骨科手术后的情况中已显示出积极效果。应制定定制的远程康复干预计划,以促进肩峰撞击综合征手术后肩部功能的恢复。本研究的目的是评估远程康复干预与肩峰下减压手术后患者常规护理相比的可行性和有效性。

方法

在一项单盲、随机对照非劣效性试验研究设计中,我们将比较接受视频会议和远程康复计划的干预组与接受传统物理治疗干预的对照组。

讨论

通过本研究,我们将进一步完善远程康复计划的初步数据集和实践经验,以评估其有效性,并与传统干预进行比较。我们还将探讨患者满意度和成本效益。患者招募正在进行中。

试验注册

ClinicalTrials.gov,NCT02909920。2016年9月14日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aeac/5324280/3cf87b6d7c9b/13063_2017_1822_Fig1_HTML.jpg

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