The application of a digital therapeutic reveals superior outcome compared to standard care in patients with anterior knee pain—a randomized controlled trial

PURPOSE: Anterior knee pain is a frequent symptom caused by disorders like patellofemoral pain syndrome or patella tendon tendinitis, which is commonly treated conservatively. The aim of the current study was to examine the effectiveness of a digital therapeutic (DT) versus German standard care through a prospective, randomized, multicenter controlled trial. METHODS: Study participants were recruited in 9 orthopedic specialist centers diagnosed with anterior knee pain and a NPRS score of ≥ 4. Stratified randomization for n = 140 participants was conducted, assigning participants to the intervention group (exclusive use of DT) or the control group (standard care). Standard care included 1-3 prescriptions for physical therapy, while the DT consisted of a 90-day personalized exercise therapy program including educational content. The primary endpoints were pain measured by NPRS and functional impairment measured by the Kujala Score. RESULTS: The use of the DT compared to the standard care showed an improvement in clinical outcomes (NPRS = - 3.7 ± 2.67 and Kujala = 18.00 ± 13.96, both p < 0.001). Both pain and function improved clinically and statistically significantly compared to the control group (ANOVA: NPRS = - 1.64 ± 0.35, p < 0.001, Kujala = 9.26 ± 2.52, p < 0.01). CONCLUSION: The use of the DT showed significant improvements in pain and function compared to the current standard therapy. These results are highly relevant for clinical practice in the treatment decision-making for patients with anterior knee pain as the DT bridges effectively gaps in the healthcare systems.