|
Timing of measurements and outline of primary and secondary outcome measures |
|||||||||
| 0 m B.A. |
3 m Q |
6 m Visit |
9 m Q |
12 m Visit |
15 m Q |
18 m Visit |
21 m Q |
24 m F.A. |
|
|
|
|||||||||
| Primary outcome measures |
|||||||||
| Joint space width |
x |
x |
|||||||
| Pain score (WOMAC) |
x |
x |
|||||||
| Function score (WOMAC) |
x |
x |
|||||||
| Secondary outcome measures |
|||||||||
| Subchondral bone quality |
x |
x |
|||||||
| Stiffness score (WOMAC) |
x |
x |
x |
x |
x |
x |
x |
x |
x |
| Quality of life (EuroQol EQ-5D) |
x |
x |
x |
x |
x |
x |
x |
x |
x |
| Medical consumption |
x |
x |
x |
x |
x |
x |
x |
x |
x |
| Side effects |
x |
x |
x |
x |
x |
x |
x |
x |
|
| CTX-II |
x |
x |
x |
x |
x |
||||
| Possible confounders/Effect modifiers |
|||||||||
| Type of OA (localised – generalised) |
x |
||||||||
| Radiological severity |
x |
x |
|||||||
| Joint function |
x |
x |
|||||||
| Age |
x |
||||||||
| Gender |
x |
||||||||
| Activity level |
x |
x |
x |
x |
x |
x |
x |
x |
x |
| Co-interventions |
x |
x |
x |
x |
x |
x |
x |
x |
x |
| Compliance (BMQ) |
x |
x |
x |
x |
x |
x |
x |
x |
|
| Compliance (pill count) |
x |
x |
x |
x |
|||||
|
Note: 0 m: 0 month of follow up, 3 m: 3 months of follow up etc. B.A.: baseline assessment. Visit: 6 monthly visit. F.A.: final assessment | |||||||||
Rozendaal et al. BMC Musculoskeletal Disorders 2005 6:20 doi:10.1186/1471-2474-6-20 |
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