Table 1 |
|
|
Outcome measures |
|
|
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 |
|
|
|
|
|
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 |
|
|
|
|
|
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 |
|
|
|
|
Bennell et al. BMC Musculoskeletal Disorders 2007 8:96 doi:10.1186/1471-2474-8-96 |
|
