Outcome variables | Data collection instrument | Measures | Time points of outcome assessment | Statistical analysis |
---|---|---|---|---|
Primary outcome | ||||
 1. Change in shoulder pain and function | SPADI (questionnaire) | Score 0–100 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
Key secondary outcomes | ||||
 1. Change in shoulder pain | SPADI (questionnaire) | Score 0–10 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 2. Change in shoulder function | SPADI (questionnaire) | Score 0–10 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 3. Clinical response | SPADI minimal important change criteriaa—no. (%) | SPADI change score (dichotomous) | 12 weeks (follow-up) | Logistic regression after 12 weeks |
 4. Impression of the treatment´s success | GPE (questionnaire) | Score 0–7 (continuous) | 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 5. and 6. Change in A- and P-ROM in the affected shoulder | Smartphone Inclinometer test protocol | Degree (continuous) | 0 and 12 weeks | ANCOVA |
 7. Number of treatments received due to shoulder symptomsb | Questionnaire | Mean number of received treatments (continuous) | 12 weeks (follow-up) | ANCOVA |
 8. Change in maximum shoulder pain intensity within the previous 24 h in the affected shoulder | NRS in questionnaire | Score 0–10 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 9. Change in shoulder pain during general activities within the previous 24 h in the affected shoulder | NRS in questionnaire | Score 0–10 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 10. Change in shoulder pain at rest within the previous 24 h in the affected shoulder | NRS in questionnaire | Score 0–10 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 11. Change in shoulder pain during sleep within the previous 24 h in the affected shoulder | NRS in questionnaire | Score 0–10 (continuous) | 0, 4, 8 and 12 weeks | Repeated-Measures, Mixed Effects Model |
 12. Change in shoulder pain during flexion/rotation/abduction in the affected shoulder | NRS / test protocol | Score 0–10 (continuous) | 0 and 12 weeks | ANCOVA |
Other exploratory outcomes | ||||
 1. Pain medication consumption | Questionnaire | Type (categorical) | 0, 4, 8 and 12 weeks | Logistic regression |
 2. Depression score | PHQ-9 (questionnaire) | Score 0–27 (continuous) | 0, 4, 8 and 12 weeks | ANCOVA |
 3. Anxiety score | GAD-7 (questionnaire) | Score 0–21(continuous) | 0, 4, 8 and 12 weeks | ANCOVA |
Sensitivity analyses | ||||
 Per-protocol analysisc |  |  |  | ANCOVA |
 As-treated analysisc |  |  |  | ANCOVA |