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Table 1 Participant eligibility criteria

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

Inclusion criteria

Exclusion criteria

Fulfil the National Institute for Health and Care Excellence (NICE) clinical criteria for osteoarthritis:

• Age ≥ 50 years;a

• Have activity related joint pain; and

• Have morning stiffness ≤30 min.

Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease)

Average knee pain intensity (overall and/or while walking) of ≥4 on 11-point numeric rating scale (NRS, where 0 = no pain; 10 = worst pain possible) in the past week

For those identified as at risk from the pre-exercise screening, general practitioner does not give medical clearance

Moderate disability due to the knee over the past week (≥ 3 on the Global Disability Rating Scale)

Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)

Knee pain of at least 6 months duration

Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke)

Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)

Inflammatory arthritis (including rheumatoid arthritis)

Current purposeful walking for exercise of ≤30 mins/day on ≤5 days/week

Fibromyalgia

Able to give informed consent and to participate fully in the interventions and the assessment procedures

Planned knee replacement/surgery (next 12 months); and/or recent knee replacement on the non- or less-painful knee (<  6 months)

Previously operated knee is the most painful knee

Intra-articular therapy use in the 12 weeks preceding enrolment

Any condition impacting decision-making/memory (e.g., Alzheimer’s, dementia)

Severe depression (> 17 on the 4-item PROMIS depression subscale)

Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)

Current purposeful walking for exercise of ≥30 mins/day on ≥5 days/week.

Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)

Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)

  1. aNote: NICE criteria for age is > 45 years; however, ≥ 50 years has been used for the present trial to limit inclusion of younger participants with trauma-induced OA