Table 1 Outcome measures
| Primary objectives outcome measures | Secondary objectives outcome measures | ||
|---|---|---|---|
| Pain and function outcomes | Menopause symptoms | Joint appearance | |
|
• Rates of eligible participant identification (screening period) • Rates of recruitment/randomisation from different sources (screening period) • Retention rates (throughout study) • Study medication compliance a • Bang’s Blinding Index (likelihood of unblinding) [40] a |
• Average hand pain (rated over 14 days preceding the study visit)c a • Pain manikin–capturing pain in other joints in the 4 weeks preceding the study visita • Functional Index for Hand OsteoArthritis (FIHOA) questionnaire [41, 42]b • Grip strength, by Jamar dynamometer [43]b • EQ-5D-5L questionnaire [44, 45]b |
• Menopause-specific Quality of Life (MENQOL) questionnaire (Intervention 1-month recall version) [38, 46, 47]b • Greene Climacteric Scale [48]b |
• Cosmesis score (single question, Michigan Hand Questionnaire) [49]b • Investigator-recorded tender and swollen joint counts a • Photographic recording of swollen hand joints a |