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三种被动水上干预对慢性非特异性下腰痛的短期效果评估:一项随机交叉临床试验的研究方案

Evaluation of short-term effects of three passive aquatic interventions on chronic non-specific low back pain: Study protocol for a randomized cross-over clinical trial.

作者信息

Schitter Agnes M, Frei Peter, Elfering Achim, Kurpiers Nico, Radlinger Lorenz

机构信息

Bern University of Applied Sciences, Department of Health Professions, Physiotherapy, Murtenstrasse 10, CH - 3008 Bern, Switzerland.

University of Hildesheim, Institute of Sport Science, Universitätsplatz 1, DE - 31141 Hildesheim, Germany.

出版信息

Contemp Clin Trials Commun. 2022 Feb 12;26:100904. doi: 10.1016/j.conctc.2022.100904. eCollection 2022 Apr.

DOI:10.1016/j.conctc.2022.100904
PMID:35243125
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8886016/
Abstract

BACKGROUND

Low back pain (LBP) is among the most common physical ailments and its chronic manifestation is a leading cause for disability worldwide. LBP is not attributable to a known diagnosis in 85% of the cases and therefore called chronic non-specific LBP (cnLBP). Passive immersion in warm water is commonly claimed to reduce muscular tension and pain, but not yet sufficiently investigated with regard to cnLBP. The current study compares three passive aquatic interventions regarding their effects on cnLBP: floating (resting in a supine immersed position on flotation devices), WATSU (a passive hands-on treatment, in which a practitioner stands in warm water, gently moving and massaging the client), and a Spa session.

METHODS

In this randomized cross-over clinical trial, all 24 adult participants with cnLBP will undergo the three interventions in balanced order with a washout-period of at least two weeks in between. Assessments will take place at baseline and follow-up of study and immediately before and after each intervention. Assessments cover the primary outcome self-reported current pain (Visual Analog Scale, range: 0-100 mm), other self-report questionnaires (addressing, e.g., personality traits or -states), and physiological parameters (e.g., measurement of spinal range of motion).

DISCUSSION

The study adds estimates of intervention-specific effect-sizes of widespread passive aquatic interventions to cnLBP. The study also points to potential underlying pain-reducing mechanisms.

TRIAL REGISTRATION

The protocol was approved by the Ethics Committee of the Canton Bern (ProjectID: 2018-00461). Trial registration is intended at ClinicalTrials.gov.

摘要

背景

腰痛是最常见的身体疾病之一,其慢性表现是全球残疾的主要原因。在85%的病例中,腰痛无法归因于已知诊断,因此被称为慢性非特异性腰痛(cnLBP)。通常认为被动浸泡在温水中可减轻肌肉紧张和疼痛,但对于cnLBP的研究尚不充分。本研究比较了三种被动水疗干预措施对cnLBP的影响:漂浮(仰卧在漂浮装置上浸泡休息)、水舞疗法(一种被动的手法治疗,治疗师站在温水中,轻轻移动并按摩客户)和水疗疗程。

方法

在这项随机交叉临床试验中,所有24名患有cnLBP的成年参与者将按平衡顺序接受这三种干预措施,每次干预之间至少有两周的洗脱期。评估将在研究的基线和随访时以及每次干预前后立即进行。评估包括主要结局自我报告的当前疼痛(视觉模拟量表,范围:0 - 100毫米)、其他自我报告问卷(例如涉及人格特质或状态)以及生理参数(例如脊柱活动范围的测量)。

讨论

该研究增加了对广泛的被动水疗干预措施对cnLBP的特定干预效应大小的估计。该研究还指出了潜在的疼痛减轻机制。

试验注册

该方案已获得伯尔尼州伦理委员会批准(项目编号:2018 - 00461)。计划在ClinicalTrials.gov上进行试验注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26e1/8886016/7046568285e6/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26e1/8886016/7046568285e6/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26e1/8886016/7046568285e6/gr1.jpg

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