Table 1 Study measures
Construct assessed | Data collection instrument | Time of collection |
|---|---|---|
Primary outcome measure | Â | Â |
Pain, symptoms, physical function and QOL | Average score of four of the KOOS subscales, KOOS4 | 0, 12, 26 and 52 weeks |
Secondary outcome measures | Data collection instrument | Time of collection |
| Â | PROMs | Â |
Pain, symptoms, ADL, QOL and Sport & Rec | The five individual subscales of KOOS | 0, 12, 26 and 52 weeks |
Health outcome | EQ-5D-3 L | 0, 12, 26 and 52 weeks |
Self-efficacy in improving pain, function and QOL | 100 mm VAS | 0, 12, 26 and 52 weeks |
Pain intensity in various situations | 100 mm VAS | 0, 12, 26 and 52 weeks |
Pain location | Region-divided body chart | 0, 12, 26 and 52 weeks |
| Â | Objective measures | Â |
Functional performance | Timed Up and Go | 0, 12, 26 and 52 weeks |
Functional performance | 20-meter walk test | 0, 12, 26 and 52 weeks |
Weight change | Percentage-wise change in weight from baseline to follow-up | 0, 12, 26 and 52 weeks |
Muscle strength | HHD - maximum isometric strength in flexion and extension | 0, 12, 26 and 52 weeks |
Pain reactions | Handheld algometer – PPTs at four sites in the peripatellar region and at m. tibialis anterior | 0, 12, 26 and 52 weeks |
Other measures | Data collection instrument | Time of collection |
Compliance with exercise | Treatment records, log-book | Continuously |
Use of medication | Questionnaire | 0, 12, 26 and 52 weeks |
Compliance with diet, insoles and patient education | A five-point scale (ranging from never to all the time) | 0, 12, 26 and 52 weeks |
Satisfaction | A five-point Likert scale | 0, 12, 26 and 52 weeks |
Adverse events | Treatment records, hospital records and questionnaire | Continuously |
Health and non-health care costs | Hospital records and questionnaire | 0, 12, 26 and 52 weeks |