Table 1 Outcome measures to be collected
Outcome measure(s) | Data collection instrument | Time line for data collection |
|---|---|---|
Primary | ||
WOSI (total score) | Mean score of 21 items (0–2100; 0 = no trouble) | 0, 4, 8, 12, 52 and 104 weeks |
Secondary (key secondary outcomes) | ||
Physical symptoms, Sport/recreation/work, lifestyle and emotions | Individual domains in the WOSI | 0, 12, 52 and 104 weeks |
Fear of movement and reinjury | Tampa Scale of Kinesiophobia | 0, 12, 52 and 104 weeks |
General health | EQ-5D-5 L | 0, 12, 52 and 104 weeks |
Pain intensities | Numeric Pain Rating Scales | 0, 12, 52 and 104 weeks |
Self-reported shoulder function | Patient Specific Functioning Scale | 0 and 12 weeks |
Self-reported and objective shoulder function | Constant-Murley Shoulder Score | 0 and 12 weeks |
Clinical shoulder instability | Clinical tests: apprehension, relocation and surprise | 0 and 12 weeks |
Shoulder proprioception (open chain) | Shoulder joint repositioning with use of laser pointer method | 0 and 12 weeks |
Shoulder proprioception (closed chain) | Nintendo Wii balance board | 0 and 12 weeks |
Maximum isometric shoulder muscle strength in 90° of abduction | Isoforce dynamometer | 0 and 12 weeks |
Demographic data and other measurements | ||
Total number of dislocations/subluxations | Questionnaire | 0 and 12 weeks |
Medication use | Questionnaire | 12 weeks |
Treatment satisfaction | Questionnaire | 12 weeks |
Patient-reported impression of treatment success | 7-point Likert scale (GPE) (ranging from 1 = very much worse to 7 = very much improved) | Throughout |
Adverse events | Physiotherapist records and questionnaire | Throughout |