Skip to main content

Table 2 Outcome measures

From: Pain reduction with oral methotrexate in knee osteoarthritis, a pragmatic phase iii trial of treatment effectiveness (PROMOTE): study protocol for a randomized controlled trial

  Month(s)
  0 3 6 9 12
Primary outcome      
Average overall knee pain severity over the previous week (0 to 10 NRS)
Secondary outcomes      
Imaging assessments:      
MRI of signal knee     
Clinical assessments:      
Knee examination     
Self-reported questionnaires:      
WOMAC 3.1 (pain, stiffness and function) - five-point Likert scale
ICOAP
11-point NRS for:
Worst knee pain severity,/ global disease activity and pain in other joints over the past week      
Satisfaction with knee function over the past 2 days      
Knee pain, aching or stiffness over the past month (no days to all days)      
Globala improvement in knee problem, pain and function  
Pain elsewhere (pain manikin)
Duration of knee pain over the past 12 months (<7 days, 1 to 4 weeks, >1 month, <3 months or >3 months)     
Onset of knee pain (last 12 months, 1 to 5 years, 5 to 10 years or 10 years or more)     
Quality of life: SF-12 v2 and OAQoL [40]    
EuroQol EQ-5D [41,42]    
Depression and anxiety: HADS    
Resource use:    
Demographics and medical history     
Brief medication questionnaire  
Concomitant medicationb
Adverse eventsb  
  1. aA six-point Likert scale: completely better, much better, better, no change, worse or much worse. bAlso recorded at 1 and 2 months. HADS, Hospital Anxiety and Depression Scale; ICOAP, Intermittent and Constant Osteoarthritis Pain; NRS, numerical rating scale; OAQoL, Osteoarthritis Quality of Life Scale; VAS, visual analogue scale; WOMAC, Western Ontario McMaster Universities Index.