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

Table 2 Outcome measures

	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)
Global^a 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 medication^b	✓	✓	✓	✓	✓
Adverse events^b		✓	✓	✓	✓

^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.

ISSN: 1745-6215