Mobile application-based digital therapeutics for frozen shoulder rehabilitation: a single-center, randomized controlled pilot study

Abstract Digital therapeutics offer promising solutions for frozen shoulder rehabilitation. This single-center, assessor-blinded, randomized controlled pilot trial compared an AI-based digital therapeutic application (ANAPA ME) with YouTube-based home exercises in 18 patients with frozen shoulder. Following baseline assessments, patients were allocated to the digital therapeutics (DTx) or conventional rehabilitation (CON) group, received a single ultrasound-guided intra-articular corticosteroid injection, and completed a 12-week exercise program. Assessments at weeks 0, 2, 4, 8, and 12 included passive range of motion (ROM), Visual Analog Scale (VAS), Constant Shoulder Score (CSS), Shoulder Pain and Disability Index (SPADI), and EuroQol-5 Dimension-5 Level (EQ-5D-5L). At 12 weeks, the DTx group achieved significantly greater side external rotation ROM ( p = 0.04) and improvement from baseline ( p = 0.042). EQ-5D-5L showed a significant group × time interaction ( p = 0.048), with greater improvement from baseline in the DTx group ( p = 0.013). No significant between-group differences were observed in VAS, SPADI, or CSS. These findings suggest that AI-based digital therapeutics may offer preliminary advantages in side external rotation ROM and health-related quality of life over conventional video-based exercises, though confirmation in larger trials is needed. This trial was registered with the Clinical Research Information Service, Korea Disease Control and Prevention Agency (registration number: PRE20250113-001) on January 13, 2025.