Table 3.
Analysis of secondary outcomes (shell).
| Time point | Intervention, number, central tendency (variability) | Control, number, central tendency (variability) | Effect measure (95% CI) | p Value |
|---|---|---|---|---|
| Back-specific functiona at | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 52 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Overall intervention effectb | .xx | |||
| Self-rated health-related QoLc at | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 52 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Overall intervention effectb | .xx | |||
| Recoveryd at | n = xx | n = xx | ||
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Adverse effects during interventione | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Adverse effects throughout trialf | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 52 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Overall intervention effectb | .xx | |||
| Serious adverse effects during interventiong | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Serious adverse effects throughout trialh | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 52 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Overall intervention effectb | .xx | |||
| Global perceived effecti at | n = xx | n = xx | ||
| 18 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 52 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Overall intervention effectb | .xx |
a
Roland-Morris Disability Questionnaire.
b
p Value is from a mixed effects model, comparing between-group differences over the entire 52-week trial.
c
Health-related quality of life.
d
A participant is considered recovered when the outcome score for pain intensity (in the past week) is either 0 or 1 on the 11-point NRS at both 18- and 26-weeks.
e
Sum of any adverse effects during intervention period.
f
Any adverse effects over the entire 52-week trial.
g
Sum of any serious adverse effects during intervention period.
h
Any serious adverse effects over the entire 52-week trial.
i
Global Back Recovery Scale.