M75.1 S46.0 M75.4
Conditions
Interventions
Group 1: Patients with rotator cuff-related conditions receive the Orthopy app as an add-on to their Usual Care (UC)- therapy). The app contains information about the condition, educational content ab
Sponsors
Orthopy Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Shoulder pain associated with functional impairment (NRS function = 6 on the day of recruitment on the NRS function) due to rotator cuff-related disorders, ICD-10 coded as: o M75.1 Rotator cuff lesion/S46.0 injury of the muscles and tendons of the rotator cuff o M75.4 Impingement syndrome of the shoulder 2. Age 18 or older 3. Exercise therapy for shoulder disorders indicated 4. Ownership of and sufficient skills in using a smartphone (iOS 12/Android 9 operating system or newer) 5. Willingness and existing technical equirements (email and internet access) to use the Orthopy app and complete the questionnaires 6. Willingness to train regularly with the app and participate in the study surveys 7. Sufficient knowledge of German 8. Participants are capable of giving consent, have full legal capacity and understand the nature, scope, significance and consequences of the examination and treatment 9. Consent to participate after receiving information
Exclusion criteria
Exclusion criteria: 1. M75.0 Adhesive inflammation of the shoulder joint capsule including: frozen shoulder, periarthropathia humeroscapularis 2. M75.2 Tendinitis of the biceps brachii muscle (isolated occurrence, acute stage, evaluated by examiner to determine whether participation in the study is possible) 3. M75.3 Calcific tendinitis in the shoulder region, including calcific bursitis in the shoulder region 4. M75.5 Bursitis in the shoulder region (isolated occurrence, acute stage, evaluated by investigator to determine whether participation in the study is possible) 5. M75.6 Labral lesion in degenerative change in the shoulder joint, including: lesion of the labrum, not described as traumatic 6. Surgical treatment of the shoulder joint in the last 12 months 7. History of previous shoulder dislocation 8. Re-rupture of the rotator cuff 9. Pregnancy (already known at the time of study inclusion) 10. (Metastatic) tumor diseases 11. Neurological diseases that make independent exercise therapy impossible (stroke, dementia, Parkinson's disease, etc.) 12. Functionally significant impairing diseases of the cervical and thoracic spine 13. Severe asthma/COPD 14. Chronic pain patients, except for study indication 15. Use of the Orthopy app or similar health applications at study inclusion or in the past 16. The person is simultaneously participating in another clinical study. 17. Other conditions that, in the opinion of the investigator, require exclusion of the participation in the study 18. Use of WHO class 2 pain medication at baseline 19. Manufacturer-specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Western Ontario Rotator Cuff Index (WORCI) after 12 weeks compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Change in subjective pain level (VAS) b. Change in subjective health status/function (Single Assessment Numeric Evaluation (SANE)) | — |
Countries
Germany
Contacts
Public ContactHagen Schmal
Universitätsklinikum Freiburg- Klinik für Orthopädie und Unfallchirurgie
Outcome results
None listed