Table 1 Participant baseline characteristics
From: PRECISE — pregabalin in addition to usual care: statistical analysis plan
Pregabalin (n = xxx) | Placebo (n = xxx) | |
|---|---|---|
Participant characteristics | ||
Female | n/N (%) | n/N (%) |
Age (years) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
BMI (kg/m2) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Currently employed | n/N (%) | n/N (%) |
Compensable leg pain | n/N (%) | n/N (%) |
Household income/week (year) (AUD) | ||
No income | n/N (%) | n/N (%) |
$1–$649 ($1–$33,799) | n/N (%) | n/N (%) |
$650–$1699 ($33,800–$88,399) | n/N (%) | n/N (%) |
$1700–$3999 ($88,400–$207,999) | n/N (%) | n/N (%) |
$4000 or more ($208,000 or more) | n/N (%) | n/N (%) |
Chose not to answer | n/N (%) | n/N (%) |
Medicine use in the last weeka | ||
Simple analgesics | n/N (%) | n/N (%) |
NSAIDs | n/N (%) | n/N (%) |
Strong opioid analgesics | n/N (%) | n/N (%) |
Combination opioid analgesics | n/N (%) | n/N (%) |
Other | n/N (%) | n/N (%) |
Occupation | ||
Manager | n/N (%) | n/N (%) |
Technician and Trade Worker | n/N (%) | n/N (%) |
Clerical and Administrative Worker | n/N (%) | n/N (%) |
Machinery Operator and Driver | n/N (%) | n/N (%) |
Professional | n/N (%) | n/N (%) |
Community and Personal Service Worker | n/N (%) | n/N (%) |
Sales Worker | n/N (%) | n/N (%) |
Labourer | n/N (%) | n/N (%) |
Health insurance | ||
None | n/N (%) | n/N (%) |
Private hospital only | n/N (%) | n/N (%) |
Private ancillary (extras) only | n/N (%) | n/N (%) |
Private hospital and ancillary (extras) | n/N (%) | n/N (%) |
DVA | n/N (%) | n/N (%) |
Chose not to answer | n/N (%) | n/N (%) |
Episode characteristics | ||
Physical examination | ||
Dermatomal pain | n/N (%) | n/N (%) |
Neurological deficit | n/N (%) | n/N (%) |
Sensory deficit | n/N (%) | n/N (%) |
Motor deficit | n/N (%) | n/N (%) |
Clinician diagnosis | ||
Spinal level affected -L3 | n/N (%) | n/N (%) |
Spinal level affected -L4 | n/N (%) | n/N (%) |
Spinal level affected -L5 | n/N (%) | n/N (%) |
Spinal level affected -S1 | n/N (%) | n/N (%) |
Spinal level affected -S2 | n/N (%) | n/N (%) |
Multiple spinal levels affected | n/N (%) | n/N (%) |
Not reported | n/N (%) | n/N (%) |
Leg pain duration (days) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Leg pain intensity (NPRS) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Back pain intensity (NPRS) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Disability (Roland Disability Questionnaire Sciatica) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Quality of life-physical score (SF-12v2) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Quality of life-mental score (SF-12v2) | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
Global Perceived Effect scale | xx.x (xx.x to xx.x), n | xx.x (xx.x to xx.x), n |
painDETECT score | ||
score ≤ 12 (neuropathic component unlikely) | n/N (%) | n/N (%) |
score 13–18 (unclear if neuropathic pain present) | n/N (%) | n/N (%) |
score ≥ 19 (neuropathic component likely) | n/N (%) | n/N (%) |