Table 2

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