Non-inferiority of a hybrid outpatient rehabilitation: a randomized controlled trial (HIRE, DRKS00028770)

Abstract

Abstract Background Physiotherapeutic telerehabilitation in various musculoskeletal and internal diseases, including back pain, might be comparable to face-to-face rehabilitation or better than non-rehabilitation. In Germany, a standardized back school for patients with chronic back pain is provided in outpatient rehabilitation centers. The effectiveness of this standardized back school was shown in a randomized controlled trial in face-to-face rehabilitation. This study examines non-inferiority of a hybrid rehabilitation applying a digital version of the standardized back school against a rehabilitation applying the face-to-face back school. Methods/design We recruit 320 patients in eight German outpatient rehabilitation centers. Patients are randomized equally to the intervention and control groups. Patients aged 18 to 65 years with back pain are included. Patients lacking a suitable private electronic device and German language skills are excluded. Both groups receive the standardized back school as part of the 3-week rehabilitation program. The control group receives the back school conventionally in face-to-face meetings within the outpatient rehabilitation center. The intervention group receives the back school online using a private electronic device. Besides the back school, the patients participate in rehabilitation programs according to the German rehabilitation guideline for patients with chronic back pain. Hence, the term “hybrid” rehabilitation for the intervention group is used. The back school consists of seven modules. We assess data at four time points: start of rehabilitation, end of rehabilitation, 3 months after the end of rehabilitation and, 12 months after the end of rehabilitation. The primary outcome is pain self-efficacy. Secondary outcomes are, amongst others, motivational self-efficacy, cognitive and behavioral pain management, and disorder and treatment knowledge. Guided interviews with patients, physicians, physiotherapists and other health experts supplement our study with qualitative data. Discussion/aim Our randomized controlled trial aims to demonstrate non-inferiority of the online back school, compared to conventional implementation of the back school. Trial registration German Clinical Trials Register (DRKS00028770, April 05, 2022).