Non-inferiority of hybrid outpatient telerehabilitation: 3-month follow-up of a randomized controlled trial.

Abstract

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. 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]). 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. Implementation of the study and enrollment of participants was conducted in 8 German outpatient rehabilitation centers. Rehabilitants aged 18-65 years with back pain were included. 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. 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. 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. 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.