Muscle activity and rehabilitation in spinal stenosis (MARSS) after conservative therapy and surgical decompression with or without fusion: Protocol for a partially randomized patient preference trial on rehabilitation timing

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-02-22 DOI:10.1016/j.conctc.2024.101273
Eduard Kurz , Philipp Schenk , Florian Brakopp , Moritz Diers , Oliver Klingel , Stefan Bone , Hans Jörg Meisel , Karl-Stefan Delank , Bernhard W. Ullrich
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Abstract

Background

Patients affected by lumbar spinal stenosis (LSS) suffer from a multifactorial degeneration of the lumbar spine resulting in narrowing of the neuroforamina and spinal canal, leading to various functional limitations. It remains unclear whether LSS patients after surgery would benefit from early post-operative rehabilitation, or if a delayed rehabilitation would be more advantageous. The purpose of this partially randomized patient preference trial is to evaluate the impact of post-operative rehabilitation timing as well as surgical intervention type on psychometric properties and functional outcomes in patients with LSS.

Methods

Data for this patient preference trial are collected before and after surgical (decompression only or decompression and fusion) and rehabilitative interventions as well as six, 12 and 24 months after completing rehabilitation. The study participants are patients diagnosed with LSS who are at least 18 years old. After a medical check-up, participants will complete patient-reported outcome measures (PAREMO-20, SIBAR, FREM-8, SF-12, SFI, ODI) and different functional assessments (functional reach test, loaded reach test, handgrip strength, standing balance control, 6-min walk test).

Ethics and dissemination

The results of this study will be published through peer-reviewed publications and scientific contributions at national and international conferences. This research has been approved by the Institutional Review Board of Martin Luther University Halle-Wittenberg (reference number: 2022-128).

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椎管狭窄症保守治疗和手术减压(无论有无融合)后的肌肉活动和康复(MARSS):关于康复时机的部分随机患者偏好试验方案
背景腰椎管狭窄症(LSS)患者的腰椎因多种因素发生退变,导致神经孔和椎管狭窄,造成各种功能障碍。目前仍不清楚腰椎管狭窄症患者术后是否能从早期康复中获益,还是延迟康复更为有利。这项部分随机的患者偏好试验旨在评估术后康复时机以及手术干预类型对 LSS 患者心理测量学特性和功能结果的影响。方法:收集手术(单纯减压或减压融合)和康复干预前后以及完成康复后 6、12 和 24 个月的患者偏好试验数据。研究参与者为年满 18 周岁、确诊为 LSS 的患者。在体检后,参与者将完成患者报告的结果测量(PAREMO-20、SIBAR、FREM-8、SF-12、SFI、ODI)和不同的功能评估(功能性伸手试验、负重伸手试验、手握力、站立平衡控制、6分钟步行试验)。本研究已获得哈雷-维滕贝格马丁路德大学机构审查委员会的批准(参考编号:2022-128)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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