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