Non-inferiority of digitally assisted outpatient rehabilitation in patients with back pain: 12-month follow-up of a randomized controlled trial

OBJECTIVE: To examine the non-inferiority of digitally assisted, multimodal rehabilitation that utilizes a digital version of a standardized back school (intervention group) compared with a rehabilitation program applying the back school conventionally in person (control group). DESIGN: Nonblinded, randomized, controlled, non-inferiority trial with 12-month follow-up after the end of rehabilitation. SUBJECTS/PATIENTS: Adults aged 18-65 years with back pain. METHODS: The back school was part of a 3-week rehabilitation program along with other treatments in accordance with the therapy standards. Eight outpatient rehabilitation centers conducted the rehabilitation program. Self-reported pain self-efficacy (10-60 points) was the primary outcome. Non-inferiority was established if the lower limit of the one-sided 95% confidence interval was greater than -4 points for pain self-efficacy. RESULTS: A total of 157 participants (55.3%) completed the 12-month follow-up. Multiple imputation of missing data allowed for inclusion of 270 participants in the analysis (intervention group: n = 127, control group: n = 143). Our primary adjusted intention- to-treat analysis demonstrated that digitally assisted rehabilitation was non-inferior to conventional rehabilitation at the 12-month follow-up (b = 0.48; 95% CI = -3.09 to ∞). CONCLUSION: This study supports the hypothesis that digitally assisted rehabilitation is a viable alternative to in-person rehabilitation for patients with back pain.