基于家庭的康复训练结合人体关键点检测治疗慢性下背痛患者：一项随机对照试验方案。

Home-based rehabilitation training with human key point detection for chronic low back pain patients: a randomized controlled trial protocol.

机构信息

Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, 510080, China.

Yinshan Future Health Technology Co., Ltd, Beijing, 100080, China.

出版信息

Trials. 2023 Nov 27;24(1):760. doi: 10.1186/s13063-023-07805-z.

DOI:10.1186/s13063-023-07805-z

PMID:38012740

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10680338/

Abstract

BACKGROUND

Core stability exercise (CSE) is a globally acknowledged intervention for managing chronic low back pain. However, the sustained adherence of patients with chronic low back pain to CSE can be challenging, mainly due to the absence of supervision and guidance from physical therapists during home-based exercise sessions. Consequently, exercise compliance tends to decline, resulting in suboptimal long-term effectiveness of the intervention. In this trial, our primary aim is to evaluate the potential therapeutic equivalence between home-based rehabilitation training employing key point identification technology and exercise guidance administered in a hospital setting.

METHODS

In this trial, we will randomly assign 104 adults with chronic low back pain (CLBP) to either an intervention or control group, with 52 participants in each group. Both interventions will consist of three weekly 0.5-h sessions of core stability exercise (CSE). The intervention group will engage in home rehabilitation training utilizing key identification technology for movement, while the control group will perform supervised exercises in a hospital setting. Outcome assessments will be conducted at 4 weeks and 16 weeks after randomization. The primary outcome measure will be the change in pain intensity based on numeric rating scale (NRS scores) from baseline to 4 weeks. Secondary outcomes will include changes in physical function (measured by the Oswestry Disability Index (ODI)) and lumbar spine mobility as well as activity participation and treatment satisfaction.

DISCUSSION

If home-based rehabilitation method is demonstrated to be non-inferior or even superior to traditional face-to-face exercise guidance, it could significantly advance the adoption of digital medical care and contribute to improving the overall health of the population.

TRIAL REGISTRATION

NCT05998434 . Registered on 16 August 2023.

摘要

背景

核心稳定性训练（CSE）是一种被全球认可的治疗慢性下背痛的干预措施。然而，慢性下背痛患者在家中进行基于运动的康复训练时，由于缺乏物理治疗师的监督和指导，其对 CSE 的持续依从性可能具有挑战性。因此，运动依从性往往会下降，从而导致干预的长期效果不理想。在这项试验中，我们的主要目的是评估基于关键点识别技术的家庭康复训练与在医院环境中进行的运动指导之间的潜在治疗等效性。

方法

在这项试验中，我们将随机分配 104 名慢性下背痛（CLBP）成年人到干预组或对照组，每组 52 名参与者。两组干预均包括每周三次、每次 0.5 小时的核心稳定性训练（CSE）。干预组将在家中使用运动关键点识别技术进行康复训练，而对照组将在医院环境中进行监督运动。在随机分组后 4 周和 16 周进行结局评估。主要结局测量指标是从基线到 4 周时疼痛强度的变化（基于数字评分量表（NRS）评分）。次要结局包括身体功能（通过 Oswestry 残疾指数（ODI）测量）和腰椎活动度的变化以及活动参与度和治疗满意度的变化。