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Table 4 Summary of measures to be collected

From: A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol

Primary outcome measures

Data collection instrument

Collection points

Average overall pain in past week

100 mm VAS

0, 12, 32, 52 weeks

Self reported physical function in past 48 hours

Physical function subscale WOMAC Osteoarthritis Index 3.1 Likert version

0, 12, 32, 52 weeks

Secondary outcome measures

  

Pain

Pain subscale WOMAC Osteoarthritis Index 3.1 Likert version

0, 12, 32, 52 weeks

Global rating of change

Overall, for pain and for function - 7 point scale

12, 32, 52 weeks

 

Perceived response to treatment - 7 point ordinal scale

12, 32, 52 weeks

Muscle strength

Isometric quadriceps and hamstrings in sitting using a force transducer

0, 12, 52 weeks

 

Isometric hip abductors - Hand held dynamometer in supine

0, 12, 52 weeks

Functional performance

Timed 20 m walk

0, 12, 52 weeks

 

30 second sit-to-stand

0, 12, 52 weeks

 

Timed Up and Go

0, 12, 52 weeks

 

Step test

0, 12, 52 weeks

Physical activity levels

Physical Activity Scale for the Elderly (PASE)

0, 12, 32, 52 weeks

 

Pedometer worn for 7 days

0, 12, 52 weeks

Health-related quality of life

Assessment of Quality of Life Instrument version 2 (AQoL II)

0, 12, 32, 52 weeks

Self-reported psychological measures

Arthritis Impact Measurement Scale 2

0, 12, 32, 52 weeks

 

Arthritis Self-Efficacy Scale

0, 12, 32, 52 weeks

 

Arthritis Self-Efficacy for Pain communication Scale

0, 12, 32, 52 weeks

 

Pain Self-Efficacy Scale

0, 12, 32, 52 weeks

 

Pain Catastrophising Scale

0, 12, 32, 52 weeks

 

Coping Strategies questionnaire

0, 12, 32, 52 weeks

 

Depression, Anxiety & Stress subscale

0, 12, 32, 52 weeks

 

Holding Back Scale

0, 12, 32, 52 weeks

 

Patient Health Questionnaire-9

0, 12, 32, 52 weeks

 

Self Efficacy for Exercise Scale

0 weeks

 

Barriers to Exercise Scale

0 weeks

 

Benefits of Exercise Scale

0 weeks

 

Barriers and enablers to home exercise

32, 52 weeks

Other measures

  

Treatment credibility

Treatment Credibility Scale

1, 12 weeks

Treatment session attendance

Therapist treatment records

During intervention

Home practice during treatment

Participant log book – number of days/times completed

Daily during intervention

 

Therapist rating of participant adherence using 11-point numeric rating scale

12 weeks

 

Self-rated using 11-point numeric rating scale

22, 32, 42, 52 weeks

Home practice during follow up

Questionnaire-number of days performed exercises/pain coping skills in past week

22, 32, 42, 52 weeks

 

Questionnaire - usefulness of pain coping skills

32, 52 weeks

Adverse events

Participant logbook

Daily during intervention

 

Questionnaire

32, 52 weeks

Healthcare usage and related costs

Questionnaire and health system

0, 12, 32, 52 weeks