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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
|
Data collection instrument
|
Time of collection
|
| |
PROMs
| |
|
Pain, symptoms, ADL, QOL and Sport & Rec
|
The five individual subscales of KOOS
|
0, 12, 26 and 52 weeks
|
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Health outcome
|
EQ-5D-3 L
|
0, 12, 26 and 52 weeks
|
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Self-efficacy in improving pain, function and QOL
|
100 mm VAS
|
0, 12, 26 and 52 weeks
|
|
Pain intensity in various situations
|
100 mm VAS
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0, 12, 26 and 52 weeks
|
|
Pain location
|
Region-divided body chart
|
0, 12, 26 and 52 weeks
|
| |
Objective measures
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|
Functional performance
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Timed Up and Go
|
0, 12, 26 and 52 weeks
|
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Functional performance
|
20-meter walk test
|
0, 12, 26 and 52 weeks
|
|
Weight change
|
Percentage-wise change in weight from baseline to follow-up
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0, 12, 26 and 52 weeks
|
|
Muscle strength
|
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
|
|
Other measures
|
Data collection instrument
|
Time of collection
|
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Compliance with exercise
|
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
|
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
|
Hospital records and questionnaire
|
0, 12, 26 and 52 weeks
|
