Table 2 Results of longitudinal linear mixed model and Fisher exact test for primary and secondary outcomes (in mean and SE for continuous data, number and percentage for count data)
From: PRECISE — pregabalin in addition to usual care: statistical analysis plan
Adjusted mean (SE) | |||
|---|---|---|---|
Pregabalin (n = xxx) | Placebo (n = xxx) | Mean difference (95 % CI) {p value} | |
Leg pain intensity (NPRS) | |||
Week 2 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 4 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 8 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Week 12 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 26 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 52 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Disability (RDQS) | |||
Week 2 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 4 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 8 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Week 12 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 26 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 52 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Back pain intensity (NPRS) | |||
Week 2 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 4 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 8 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Week 12 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 26 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 52 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Global Perceived Effect | |||
Week 2 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 4 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 8 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Week 12 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 26 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 52 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Quality of life - physical score (SF12-v2) | |||
Week 2 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 4 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 8 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Week 12 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 26 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 52 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Quality of life - mental score (SF12-v2) | |||
Week 2 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 4 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 8 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Week 12 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 26 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | |
Week 52 | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x) {p value} |
Work absenteeism | |||
Hours absent from work | xxx.x (xxx.x to xxx.x), n | xxx.x (xxx.x to xxx.x), n | xxx.x (xxx.x to xxx.x) {p value} |
Use of other treatments | |||
Participants using other medicines {Fisher test} | n/N (%) | n/N (%) | xx.x (xx.x to xx.x) {p value} |
Participants using health services | n/N (%) | n/N (%) | xx.x (xx.x to xx.x) {p value} |