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分层混合物理治疗干预对非特异性下腰痛患者 3 个月疗效的影响:聚类随机对照试验。

The 3-Month Effectiveness of a Stratified Blended Physiotherapy Intervention in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.

机构信息

Research Group Empowering Healthy Behaviour, Department of Health Innovations and Technology, Fontys University of Applied Sciences, Eindhoven, Netherlands.

Center for Physical Therapy Research and Innovation in Primary Care, Julius Health Care Centers, Utrecht, Netherlands.

出版信息

J Med Internet Res. 2022 Feb 25;24(2):e31675. doi: 10.2196/31675.

Abstract

BACKGROUND

Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients' self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients' physical functioning.

OBJECTIVE

This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP.

METHODS

The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up.

RESULTS

Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference -1.96, 95% CI -4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference -16.39, 95% CI -27.98 to -4.79) and several secondary outcomes.

CONCLUSIONS

The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy.

TRIAL REGISTRATION

ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s12891-020-3174-z.

摘要

背景

患者教育、家庭为基础的运动治疗以及关于恢复正常活动的建议是针对非特异性下腰痛(LBP)患者的既定物理治疗选择。然而,物理治疗干预对健康相关结果的有效性在很大程度上取决于患者的自我管理和对运动及体育活动建议的坚持。e-Exercise LBP 是一种最近开发的分层混合护理干预措施,包括集成了面对面物理治疗的智能手机应用程序。基于网络应用程序对患者自我管理技能和对运动及体育活动建议的坚持的积极影响,假设 e-Exercise LBP 将改善患者的身体机能。

目的

本研究旨在比较非特异性 LBP 患者接受分层混合物理治疗(e-Exercise LBP)与面对面物理治疗在短期(3 个月)内对身体机能的影响。

方法

本研究设计为多中心聚类随机对照试验,采用意向治疗分析。邀请年龄≥18 岁的非特异性 LBP 患者参加研究。患者接受分层混合物理治疗或面对面物理治疗。两种干预均按照荷兰非特异性 LBP 物理治疗指南进行。混合物理治疗根据患者持续发生 LBP 的风险,使用 Keele STarT Back 筛查工具进行分层。主要结局是身体机能(Oswestry 残疾指数,范围 0-100)。次要结局包括疼痛强度、恐惧回避信念和自我报告的依从性。在基线和 3 个月随访时进行测量。

结果

分层混合物理治疗组(104/208,50%)和面对面物理治疗组(104/208,50%)的身体机能均有明显改善,且具有临床意义和统计学意义;但组间无统计学意义或临床意义上的差异(平均差异-1.96,95%CI-4.47 至 0.55)。对于次要结局,分层混合物理治疗在恐惧回避信念和自我报告的依从性方面显示出统计学意义上的组间差异。在发生持续性 LBP 风险较高的患者(13/208,6.3%)中,分层混合物理治疗在身体机能(平均差异-16.39,95%CI-27.98 至-4.79)和几个次要结局方面显示出统计学意义上的组间差异。

结论

在非特异性 LBP 患者中,分层混合物理治疗干预措施 e-Exercise LBP 在短期内改善身体机能方面并不优于面对面物理治疗。对于分层混合物理治疗和面对面物理治疗,组内改善均具有临床意义。为了能够决定是否应在日常物理治疗实践中实施 e-Exercise LBP,未来的研究应侧重于长期成本效益,并确定哪些患者最受益于分层混合物理治疗。

试验注册

ISRCTN 注册表,编号 ISRCTN94074203;https://doi.org/10.1186/ISRCTN94074203。

国际注册报告标识符(IRRID):RR2-https://doi.org/10.1186/s12891-020-3174-z。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f69c/8917429/9fc5e7a7e7f5/jmir_v24i2e31675_fig1.jpg

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