Table 3. Difference in Between-Group Standard Score Change between Outcomes Considered and WOMAC Pain Subscale.
Outcome | WOMAC pain subscale between-groups standard score difference (reference)* | |||||
Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | ||
WOMAC Pain Subscale (Reference) | 0.02 (-0.16 to 0.20), 0.85 | -0.37 (-0.55 to -0.18), <0.001 | -0.44 (-0.63 to -0.26), <0.001 | -0.38 (-0.57 to -0.19), <0.001 | -0.26 (-0.45 to -0.07), 0.01 | |
Outcome | Difference from WOMAC pain subscale, in standard score units** | |||||
Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | ||
Individual Outcomes | WOMAC Physical Function Subscale | -0.10 (-0.25 to 0.06), 0.22 | -0.04 (-0.21 to 0.12), 0.59 | -0.01 (-0.18 to 0.16), 0.90 | -0.04 (-0.22 to 0.15), 0.70 | -0.07 (-0.25 to 0.11), 0.46 |
WOMAC Stiffness Subscale | -0.22 (-0.38 to -0.07), 0.01 | -0.15 (-0.31 to 0.01), 0.07 | -0.10 (-0.27 to 0.06), 0.22 | -0.16 (-0.34 to 0.02), 0.09 | -0.17 (-0.35 to 0.01), 0.07 | |
Number of RM Pills Taken/day | -0.10 (-0.26 to 0.05), 0.20 | 0.04 (-0.13 to 0.20), 0.66 | 0.13 (-0.03 to 0.30), 0.12 | 0.13 (-0.05 to 0.31), 0.17 | 0.02 (-0.17 to 0.20), 0.85 | |
Composite Outcomes | Composite 1: WOMAC pain & number of RM pills | -0.03 (-0.19 to 0.13), 0.71 | -0.04 (-0.21 to 0.12), 0.60 | 0.00 (-0.17 to 0.16), 0.96 | -0.01 (-0.19 to 0.18), 0.94 | -0.04 (-0.22 to 0.15), 0.69 |
Composite 2: WOMAC Pain, Stiffness, & Function | -0.11 (-0.26 to 0.05), 0.17 | -0.07 (-0.24 to 0.09), 0.38 | -0.05 (-0.21 to 0.12), 0.57 | -0.07 (-0.26 to 0.11), 0.42 | -0.09 (-0.27 to 0.10), 0.36 | |
Composite 3: WOMAC P, S, F, & number of RM pills | -0.11 (-0.27 to 0.05), 0.17 | -0.09 (-0.25 to 0.07), 0.28 | -0.05 (-0.22 to 0.12), 0.56 | -0.09 (-0.27 to 0.09), 0.34 | -0.09 (-0.28 to 0.09), 0.33 |
This table outlines the difference in standard score between the control group, and the treatment group, in the variables of interest, at different time points in the study. Values shown are mean (95% CI), p. *This row indicates the difference in standard score between placebo and treatment in the WOMAC pain subscale, at each study time point. Negative values indicate greater pain reduction in the treatment group than the control group, and vice versa. For example, at week 4, the standardised WOMAC pain score in the treatment group reduced by 0.37 points more than the control group at week 4, indicating a greater reduction in pain in the treatment group at week 4. **These rows indicate how the between-groups difference in the other pain outcomes compared to the WOMAC pain subscale. For example, at week 2, the between group difference in the WOMAC physical function standard score was -0.08, indicating that the between group difference differed from the WOMAC pain subscale difference by -0.10 points. This indicates that there was an average greater reduction in pain in the treatment group compared to the control group, in the WOMAC function subscale, as compared to the WOMAC pain subscale, in the same patients at the same time point, and therefore that the WOMAC physical function subscale showed greater sensitivity to a change in pain at this time point than the WOMAC pain subscale. More negative values indicate increased sensitivity to change in the outcome shown, relative to the WOMAC pain subscale. Positive values indicate greater sensitivity to change in the WOMAC pain subscale. RM = rescue medication