Primary outcome measures | Data collection instrument | Collection points |
---|---|---|
Average pain in past week | 100 mm VAS | 0, 13, 36 weeks |
Physical function in past 48 hours | WOMAC Osteoarthritis Index 3.1 Likert version | 0, 13, 36 weeks |
Secondary outcome measures | Â | Â |
Pain, function, and stiffness | HOOS (incorporating WOMAC) | 0, 13, 36 weeks |
Health-related quality of life | Assessment of Quality of Life Instrument version 2 (AQoL II) | 0, 13, 36 weeks |
Patient's global rating of change overall and for pain and function | 7-point ordinal scale | 13, 36 weeks |
Self efficacy | Arthritis Self-efficacy scale | 0, 13, 36 weeks |
Pain catastrophizing | Pain Catastrophizing Scale | 0, 13, 36 weeks |
Coping strategies | Coping Strategies questionnaire | 0, 13, 36 weeks |
Objective functional performance | Timed 40 m walk Timed stair climb (ascent and descent) 30 second sit-to-stand | 0, 13 weeks |
Standing balance | Step test 4-square step test | 0, 13 weeks |
Hip range of motion | Clinical methods and inclinometer | 0, 13 weeks |
Hip and knee muscle strength | Isometric - isokinetic dynamometer (quadriceps and hamstrings) and instrumented manual muscle tester (hip flexors, extensors, abductors, rotators) | 0, 13 weeks |
Gait biomechanics (in a subset) | 3-dimensional motion analysis system | 0, 13 weeks |
Other measures | Â | Â |
Physical activity levels | Physical Activity Scale for the Elderly (PASE) Pedometer worn for 7 days | 0, 13, 36 weeks |
Treatment credibility | Treatment Credibility Scale | 1,12 weeks |
Participant success of blinding | Questionnaire | 13, 36 weeks |
Healthcare consumption and related costs | Questionnaire; health system records | 0, 5, 9, 13, 36 weeks |
Adverse events | Participant log-book | Throughout |
Adherence - treatment session attendance; home exercise or gel application | Participant log-book; Therapist treatment records; Questionnaire | Throughout |