M75
Conditions
Interventions
Group 1: Patients in the intervention arm receive access to the digital health application (DiGA) companion® shoulder, which includes a 90-day personalized exercise therapy with evidence-based exercis
Sponsors
PrehApp GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis ICD-10: M75 and fully weight-bearing - Maximum pain intensity of the last 7 days measured via NPRS =4 - Suitability for conservative therapy - Ability of the participant to understand the nature and scope of the data collection and the training program - Availability of written consent for data collection - Fulfilment of the technical requirements (internet access with recommended browser: Edge, Chrome, Safari; playback medium: tablet, smartphone, PC, smart TV, laptop, etc.) - Willingness to participate in the assessments and all other study procedures, in particular willingness to train regularly with the app - Sufficient knowledge of written and spoken German
Exclusion criteria
Exclusion criteria: - Bony, cartilaginous or other lesions (M75.8) and unspecified (M75.9) lesions of the shoulder and lesions of the shoulder joint capsule, chronic instability of the shoulder and isolated tendinitis of the biceps brachii muscle - Traumatic lesions of the shoulder - Planned surgical measures or other (inpatient) treatments that prevent participation in the study and are planned within the next 90 days after inclusion in the study - Patients who are currently undergoing physiotherapy treatment for their shoulder - Simultaneous or planned use of a comparable app in the target indication or participation in a comparable intervention study within the next 90 days - Previous use of the companion® shoulder app or comparable digital applications in the target indication - Insufficient reading ability or lack of understanding of the German language - Mental or physical limitations that prevent the content of the app from being understood correctly or the exercises from being performed correctly - Perceptual limitations, e.g. due to medication or injuries (especially vision, hearing, balance), unless the limitations are compensated for by an appropriate aid (e.g. glasses) - Pregnancy - Contraindications according to the instructions for use (acute infection, e.g. with fever) - Chronic pain or other conditions requiring long-term medication or non-drug treatment that, in the opinion of the investigator, may have an impact on study participation or study results - Other known conditions, comorbidities or concomitant treatments that, in the opinion of the investigator, could bias the study results and/or argue against participation in the study according to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder-specific pain reduction measured with the Numeric Pain Rating Scale (NPRS) after 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder-specific functional improvement measured with the Shoulder Pain and Disability Index (SPADI) after 90 days Number of days of incapacity for work due to illness within the survey period measured via self-reporting at 1 measurement point (day 90) | — |
Countries
Germany
Contacts
Public ContactMichael Hackl
Universitätsklinikum Mannheim
Outcome results
None listed