混合门诊远程康复治疗的非劣效性:随机对照试验的 3 个月随访。

IF 3.3 3区 医学 Q1 REHABILITATION
Richard Albers, Stella Lemke, David Fauser, Sebastian Knapp, Gert Krischak, Matthias Bethge
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引用次数: 0

摘要

背景:国际研究发现,与面对面康复或不进行康复相比,远程康复对背痛患者的治疗效果相当或更好。目的:研究为期三周的数字辅助多模式康复治疗(干预组[IG])与同样的面对面康复治疗(对照组[CG])的非劣效性:我们的研究是一项非盲多中心随机对照试验。招募时间为 2022 年至 2023 年。我们对康复结束时和3个月后的结果进行了分析:研究的实施和参与者的招募在德国8家门诊康复中心进行:方法:采用计算机生成的区组随机法,将 284 名背痛患者随机分配到 IG 或 CG 组。我们排除了 14 名患者,因为他们撤回了同意书并要求删除其数据。我们最终纳入了 270 名患者(IG:N.=127,CG:N.=143)。主要结果是自我报告的疼痛自我效能感(10-60 分)。次要结果包括当前健康状况和疼痛:我们的主要调整意向治疗分析表明,在康复结束时(b=-0.55;95% CI=-2.75至∞)和3个月随访时(b=0.24;95% CI=-2.86至∞),混合数字辅助康复治疗效果不优于面对面康复治疗。这些结果与未经调整的意向治疗分析、调整后的完整病例分析和调整后的按协议分析结果一致。对次要结果进行了优劣检验。我们的主要调整后意向治疗分析发现,次要结果没有明显的组间差异:临床康复影响:混合数字辅助康复可提高康复的灵活性和可及性。进一步的研究应探讨康复的哪些部分和哪些时间段可以数字化而不会降低效果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Non-inferiority of hybrid outpatient telerehabilitation for patients with back pain: 3-month follow-up of a randomized controlled trial.

Background: International studies identified comparable or better effects for telerehabilitation compared with face-to-face rehabilitation or no rehabilitation in people with back pain. In German rehabilitation centers, a standardized back school for patients with back pain is provided usually face-to-face as part of a multimodal rehabilitation program.

Aim: To examine the non-inferiority of a three-week, digitally assisted, multimodal rehabilitation that applies a digital version of a standardized back school (intervention group [IG]) against the same rehabilitation program applying the back school face-to-face (control group [CG]).

Design: Our study was a non-blinded multicenter randomized controlled trial. Recruitment was conducted from 2022 to 2023. We analyzed outcomes at the end of rehabilitation and 3 months later.

Setting: Implementation of the study and enrollment of participants was conducted in 8 German outpatient rehabilitation centers.

Population: Rehabilitants aged 18-65 years with back pain were included.

Methods: 284 patients with back pain were randomized into the IG or CG using computer-generated block randomization. We excluded 14 patients as they withdrew their consent and requested removal of their data. We finally included 270 patients (IG: N.=127, CG: N.=143). The primary outcome was self-reported pain self-efficacy (10-60 points). Secondary outcomes were, amongst others, current health status and pain.

Results: Our primary adjusted intention-to-treat analysis demonstrated that hybrid digitally assisted rehabilitation was non-inferior to face-to-face rehabilitation at the end of rehabilitation (b=-0.55; 95% CI=-2.75 to ∞) and at the 3-month follow-up (b=0.24; 95% CI=-2.86 to ∞). These results were in line with a non-adjusted intention-to-treat analysis, an adjusted complete case analysis, and an adjusted per-protocol analysis. Secondary outcomes were tested for superiority. Our primary adjusted intention-to-treat analysis found no significant group differences in the secondary outcomes.

Conclusions: This study provides evidence that hybrid digitally assisted rehabilitation in patients with back pain is a sound alternative to face-to-face rehabilitation in an outpatient rehabilitation setting.

Clinical rehabilitation impact: Hybrid digitally assisted rehabilitation can improve flexibility and access to rehabilitation. Further studies should examine which components and which time frame of rehabilitation can be digitized without any loss of effectiveness.

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来源期刊
CiteScore
8.50
自引率
4.40%
发文量
162
审稿时长
6-12 weeks
期刊介绍: The European Journal of Physical and Rehabilitation Medicine publishes papers of clinical interest in physical and rehabilitation medicine.
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