Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-Person Therapeutic Exercise with Education: A Randomized Controlled Pilot Study

Abstract

<jats:p>Background: Chronic lower back pain (CLBP) is a global health issue leading to significant disability and socioeconomic burden. Traditional treatments, including exercise and cognitive behavioral therapy (CBT), are often limited by physical and temporal constraints. This study aimed to evaluate the efficacy of multidisciplinary digital therapeutics (MORA Cure LBP) compared to conventional treatments. Methods: This multicenter, randomized, controlled pilot study enrolled 46 participants. Participants were randomly assigned in a 1:1 ratio to either a MORA Cure LBP group or control group, which received conventional treatment. Results: At eight weeks, both groups demonstrated improvements compared to baseline. No statistically significant differences were observed between the MORA Cure LBP and control groups in reductions in usual pain intensity (MORA Cure LBP: 3.1 ± 1.9 vs. control: 3.0 ± 1.5, p = 0.809), worst pain intensity (MORA Cure LBP: 5.00 ± 2.18 vs. control: 4.27 ± 1.83, p = 0.247), and functional disability (ODI, MORA Cure LBP: 15.6 ± 9.6 vs. control: 15.6 ± 10.0, p > 0.999). Compliance was significantly higher in the MORA Cure LBP group during the first 4 weeks (MORA Cure LBP: 74.7% ± 27.4 vs. control: 53.1% ± 28.6, p < 0.001). Conclusions: Both multidisciplinary digital therapeutics (MORA Cure LBP) and conventional treatments were effective in reducing pain and functional disability in patients with CLBP, with no significant differences between the two groups. Digital therapeutics, particularly those that integrate CBT and exercise, offer promising alternatives to conventional therapies by improving accessibility and potentially enhancing patient engagement.