Screening | Double-blind period | |||
Screening/ baseline assessment | Randomisation | 1–5 months | 6 months | |
Study visit (onsite or telehealth) | X | X | ||
Telephone interview (monthly) | X | |||
Informed consent | X | |||
Knee X-ray | X | |||
Blood test | X | |||
Medical history/conditions | X | X | ||
Medication | X | X | ||
Employment and education | X | |||
Smoking and alcohol | X | |||
Questionnaires | ||||
Knee VAS | X | X | X | |
WOMAC | X | X | ||
PainDETECT | X | X | ||
Hand VAS | X | X | X | |
Multisite pain | X | X | ||
AQoL | X | X | ||
IPAQ | X | X | ||
Physical examination | ||||
Height, weight* | X | X | ||
Compliance and safety (adverse events) | X | X | ||
Dispense medication | X |
*Height and weight will be self-reported if the visit is via telehealth.
AQoL, assessment of quality of life; IPAQ, international physical activity questionnaire; VAS, Visual Analogue Scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.