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Table 4 Primary and secondary outcomes

From: OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain—a statistical analysis plan

 

Opioid (n = xxx)

Placebo (n = xxx)

Mean difference (95% CI), p value

Pain Intensity (BPI-PS)

   

 Week 2

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 4

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

 Week 12

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

 Week 26

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 52

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Physical functioning - generic (BPI-IS)

   

 Week 2

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 4

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

 Week 12

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Physical functioning - back (RMDQ)

   

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Physical functioning – neck (NDI)

   

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Quality of life – physical score (SF-12v2)

   

 Week 2

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 4

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

 Week 12

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Quality of life – mental score (SF-12v2)

   

 Week 2

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 4

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

 Week 12

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Global perceived effect scale

   

 Week 2

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 4

xx.x (xx.x), n

xx.x (xx.x), n

 

 Week 6

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

 Week 12

xx.x (xx.x), n

xx.x (xx.x), n

xx.x (xx.x to xx.x), p = 0.xxx

Time to recovery (days)

Median (IQR)

Median (IQR)

Log-rank p = 0.xxx

Recovered (yes)

   

 Week 2

n (%)

n (%)

 

 Week 4

n (%)

n (%)

 

 Week 6

n (%)

n (%)

p = 0.xxx

 Week 12

n (%)

n (%)

p = 0.xxx

  1. BPI-PS Brief Pain Inventory Pain Severity, BPI-IS Brief Pain Inventory Interference Subscale, RMDQ Roland-Morris Disability Questionnaire, NDI Neck Disability Index, SF-12 Short Form 12 Item Survey
  2. Note: We also intend to include similar looking tables for adjusted analyses and for analyses of imputed data as supplements