Table 3

Summary of measures to be collected

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


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


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


Bennell et al. BMC Musculoskeletal Disorders 2010 11:238   doi:10.1186/1471-2474-11-238

Open Data