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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