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Table 5 Summary of measures to be taken

From: The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis – a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis

Domain

Data collection instrument

Time points

Baseline

After 1st treatment session

12 weeks

6 M

12 M

Descriptive data

 Age, gender, weight, height, body mass index

 

X

    

 Duration of knee OA symptoms

 

X

    

 Educational level, postcode

 

X

    

 Treatment and medication use in past month

 

X

 

X

X

X

 Problems in other joints

 

X

    

 Co-morbidities

Functional Co-morbidity Index

X

    

Primary outcome measures

 Physical activity level

Average daily step count via wrist-worn accelerometry

X

 

X

X

X

 OA knee symptoms in past 48 h

WOMAC Total score (includes pain, physical function, stiffness subscales)

X

 

X

X

X

Secondary outcome measures

 Average knee pain past week

11-point NRS

X

 

X

X

X

 Average knee pain during walking past week

11-point NRS

X

 

X

X

X

 Physical activity level

Daily minutes of sedentary, light, moderate, vigorous activity via wrist-worn accelerometry

X

 

X

X

X

 Knee pain past 48 h

WOMAC pain subscale

X

 

X

X

X

 Knee function past 48 h

WOMAC function subscale

X

 

X

X

X

 Depression past week

4-item PROMIS depression subscale

X

 

X

X

X

 Anxiety past week

4-item PROMIS anxiety subscale

X

 

X

X

X

 Stress past month

4-item PSS

X

 

X

X

X

 Fear of movement

Brief FOM questionnaire

X

 

X

X

X

 Pain catastrophising

PCS

X

 

X

X

X

 Health related quality of life

EQ-5D-5L

X

 

X

X

X

 Knee perception

FREKAQ

X

 

X

X

X

 Global rating of change

7 point ordinal scale

  

X

X

X

Mediators

 OA/activity Conceptualisation

Osteoarthritis and Physical Activity Conceptualisation Scale

X

 

X

X

X

 Pain self-efficacy

PSEQ

X

 

X

X

X

 Exploratory: Implicit movement bias

Implicit association task

X

 

X

  

 Exploratory: Implicit environmental bias

Distance estimation task

Hill steepness estimation task

X

 

X

  

 Exploratory: Pain sensitivity to activity

Pain pre−/post- 6 min walk task

X

 

X

  

Exploratory objective factors and questionnaires (potential modulators/moderators)

 Implicit motor imagery

Left/right judgement task

X

 

X

  

 Tactile acuity at the knee

Two point discrimination task

X

 

X

  

 OA pain conceptualisation

OA pain drawing task

X

   

X

 Self-regulated learning ability

Items from the Motivated Strategies for Learning and Regulation of Learning questionnaires

X

 

X

X

X

Resource use

 Health care usea

Resource use associated with the delivery of the intervention. Self-reported use of health services and co-interventions; MBS; and hospital admissions and emergency department presentations from administrative datasets

X

 

X

X

X

 Medication usea

Self-reported medication use and PBS data from administrative datasets

X

 

X

X

X

Additional outcomes

 Expectation of treatment outcome

5 point ordinal scale

 

X

   

 Treatment credibility

Modified Treatment Credibility/Expectancy Questionnaire

 

X

   

 Intention to exercise

7 point ordinal scales (commitment, motivation, determination to exercise)

 

X

X

X

X

 COVID-19 impact on physical activity

7-point ordinal scale

X

 

X

X

X

 Adherence

Self-rated adherence to walking and strengthening program, 11-point NRS and number of days in past week exercise performed

  

X

X

X

Number of in-person sessions attended

  

X

X

X

Number of telehealth sessions attended

  

X

  

Review of patient diary

    

X

 Harms

Adverse events

  

X

X

X

 Blinding

Participant blinding assessed via allocation guesses (and reasons); then forced choice

    

X

Outcome assessor blinding (same method)

  

X

  

Therapist blinding (same method)

    

Xb

 Therapist related factors

Beliefs about exercise; self-rated via Therapist Beliefs about Exercise Questionnaire

X

   

Xc

Beliefs about pain; self-rated via Pain Attitudes and Beliefs Scale for Physiotherapists

X

   

Xc

Pain knowledge; assessed via rNPQ

X

   

Xc

Perceived intervention credibility; assessed via modified intervention credibility and expectancy questionnaire

X

 

Xd

 

Xd

Perceived connection with participant; self-rated via 101-point NRS Connectedness Scale

  

X

  
  1. aData on MBS, PBS and emergency department presentations and hospital admissions will be sourced from government-held administrative datasets for the entire 12 month follow-up period at its conclusion. bMeasured at end of trial (recruitment complete); aim is to determine if the ‘Best practice control group’ therapists thought they were the intervention group of interest. cMeasured at baseline (pre-training), post-training, and end of trial (recruitment complete). dMeasured after pre-trial training (baseline), after the first 12 weeks of treatment (pilot participant), mid-way through the trial (i.e., half-way through recruitment), and at the end of the trial (recruitment complete)