Primary Outcomes | Measurement |
---|---|
Average pain in the past week | 11 point horizontal numeric rating scale (end descriptors of 0 = no pain and 10 = worst pain possible) |
Medial tibial compartment cartilage volume | Magnetic resonance imaging |
Secondary Outcomes | Â |
Pain, stiffness and physical function in past 48 hours | WOMAC Osteoarthritis Index – Likert version |
Global perceived response to treatment for pain and for function | Ordinal scale (1-much worse, 2-slightly worse, 3-no change, 4-slightly better, 5-much better) at study completion |
Health-related quality of life | Assessment of Quality of Life index (AQol) |
Physical activity levels | • Physical Activity Scale for the Elderly (PASE) • Pedometer worn twice for one week |
Other measures | Â |
Compliance | • Daily hours of use recorded in log-book • 11 point horizontal numeric rating scale (end descriptors of 0 = not at all and 10 = completely as instructed) at study completion |
Discomfort with insoles | • Assessed weekly in log-book on 5-point ordinal scale (1 = no discomfort, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe discomfort) • 11 point horizontal rating scale (end descriptors of 0 = extremely comfortable and 10 = extremely uncomfortable) at study completion |
Other adverse effects | Log-book and open probe questionning |