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Table 1 Outcome measures

From: Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

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