Effectiveness of self-training with a web-based digital health application vs. physiotherapy in the treatment of disorders of the patella: a randomized controlled trial (Preprint)

BACKGROUND Disorders of the patella are among the most prevalent knee injuries. While exercise therapy is widely accepted as an effective treatment strategy, the positive effects of conventional exercise therapy under the guidance of a physiotherapist may be offset by inherent limitations such as difficulties in scheduling appointments or statuary policies restricting the number of training sessions. Home-based exercise interventions using digital health applications (DHA) may help address some of these limitations. OBJECTIVE The aim of this study was to assess the efficacy of a 12-week exercise intervention utilizing a web-based DHA (Mawendo, Biberach, Germany) for improving knee function and/or reducing pain in patients with disorders of the patella (ICD-10 M22). METHODS The outcomes of the DHA intervention group (IG DHA) were compared to a control group that received conventional physiotherapy covered by statutory health insurance in Germany (CG SHI-PT). A total of 259 patients with diagnosed disorders of the patella were included in the trial and randomly allocated to IG DHA (n=136) and CG SHI-PT (n=123). The trial was registered with the DRKS (German Clinical Trials Register; WHO Primary Register) under No. DRKS00023454. Two primary endpoints were examined: 1) ‘Knee function’ (KOOSADL subscale, range 0-100 points (p)) 2) ‘Knee pain’ (visual analogue scale, VAS, range 0-100 p) Participants were asked to complete two surveys; one before the first therapy session (PRE) and one after completing the treatment period of 12 weeks (POST). RESULTS Training with the DHA resulted in a 4.5-fold greater improvement in ‘knee function’ (PRE-POST differences in KOOSADL Score; IG DHA: 15.7 p (95 % CI [13.7; 17.6]) vs. CG SHI-PT: 3.5 p (95 % CI [1.5; 5.5])) and a 3.5-fold greater reduction in ‘knee pain’ (PRE-POST differences in VAS pain score; IG DHA: -22.5 p (95 % CI [-25.2; -19.9]) vs. CG SHI-PT: -6.5 p (95 % CI [-8.7; -4.4])) compared to SHI-PT. Only the improvements in IG DHA exceeded the limits of clinical relevance. The differences between the treatment groups (KOOSADL score -10.1 p (95 % CI [Inf; -8.0]), VAS pain score 14.3 p (95 % CI [11.7; Inf])) were statistically significant (P < .001) for both endpoints in favor of IG DHA. No effect was found for age or sex. The reported use of pain medication decreased substantially in IG DHA, and showed almost no change in CG SHI-PT. CONCLUSIONS Our findings indicate that the investigated DHA is superior to SHI-PT for treating disorders of the patella. DHA has therefore been approved by the German Federal Institute for Drugs and Medical Devices for the treatment of disorders of the patella in persons of all sexes aged 12 and over. CLINICALTRIAL The trial was registered with the DRKS (German Clinical Trials Register; WHO Primary Register; https://drks.de/search/de) under No. DRKS00023454.