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

Abstract

Background Despite well-established benefits of physical activity for knee osteoarthritis (OA), nine of ten people with knee OA are inactive. People with knee OA who are inactive often believe that physical activity is dangerous, fearing that it will further damage their joint(s). Such unhelpful beliefs can negatively influence physical activity levels. We aim to evaluate the clinical- and cost-effectiveness of integrating physiotherapist-delivered pain science education (PSE), an evidence-based conceptual change intervention targeting unhelpful pain beliefs by increasing pain knowledge, with an individualised walking, strengthening, and general education program. Methods Two-arm, parallel-design, multicentre randomised controlled trial involving 198 people aged ≥50 years with painful knee OA who do not meet physical activity guideline recommendations or walk regularly for exercise. Both groups receive an individualised physiotherapist-led walking, strengthening, and OA/activity education program via 4x weekly in-person treatment sessions, followed by 4 weeks of at-home activities (weekly check-in via telehealth), with follow-up sessions at 3 months (telehealth) and 5 and 9 months (in-person). The EPIPHA-KNEE group also receives contemporary PSE about OA/pain and activity, embedded into all aspects of the intervention. Outcomes are assessed at baseline, 12 weeks, 6 and 12 months. Primary outcomes are physical activity level (step count; wrist-based accelerometry) and self-reported knee symptoms (WOMAC Total score) at 12 months. Secondary outcomes are quality of life, pain intensity, global rating of change, self-efficacy, pain catastrophising, depression, anxiety, stress, fear of movement, knee awareness, OA/activity conceptualisation, and self-regulated learning ability. Additional measures include adherence, adverse events, blinding success, COVID-19 impact on activity, intention to exercise, treatment expectancy/perceived credibility, implicit movement/environmental bias, implicit motor imagery, two-point discrimination, and pain sensitivity to activity. Cost-utility analysis of the EPIPHA-KNEE intervention will be undertaken, in addition to evaluation of cost-effectiveness in the context of primary trial outcomes. Discussion We will determine whether the integration of PSE into an individualised OA education, walking, and strengthening program is more effective than receiving the individualised program alone. Findings will inform the development and implementation of future delivery of PSE as part of best practice for people with knee OA. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12620001041943 (13/10/2020).

Item development and pre-testing of an Osteoarthritis Conceptualisation Questionnaire to assess knowledge and beliefs in people with knee pain

“…Eighteen people (10 female, 8 male) with painful knee osteoarthritis were recruited in South Australia, with a mean age of 71.8 (±7.5). Eight were recruited from the RCT ineligibility list (too physically active to be eligible for the trial) [ 44 ]. Seven were recruited via posters, social media, and mailing lists.…”

“…Seven were recruited via posters, social media, and mailing lists. Three participants were recruited from those who had completed the RCT intervention pilot study [ 44 ]. Table 3 provides the participant demographic characteristics/clinical measures.…”

“…Two members of the expert panel (DSB, ARV) conducted an informal literature review to synthesise contemporary osteoarthritis pathogenesis [ 5 , 8 , 10 , 13 , 15 , 39 – 41 ], and to identify conceptualisations about osteoarthritis and exercise/activity held by people with lived experience of osteoarthritis [ 6 , 7 , 13 , 14 , 20 , 42 ]. Five target concepts were adapted from the Explain Pain Protectometer curriculum [ 43 , 44 ] representing best practice contemporary pain science education [ 45 ]. The five target concepts were: 1) learning about knee osteoarthritis is an effective intervention and the basis of treatment; 2) knee osteoarthritis is a mild chronic (and sometimes painful) inflammatory, changeable bodily process that manifests in the knee; 3) pain is a protective process and one of many protective systems and processes in the body; 4) pain is completely dependent on context; 5) healing and change are irresistible forces of nature.…”

“…Participants were asked to (1) define a series of words and phrases used in the provisional items; (2) answer a series of questions about each item; (3) answer questions about their perceptions of the purpose of the questionnaire as a whole (as an assessment of face validity). The RCT pilot participants [ 44 ] were also asked several additional questions based on their experience in that trial; those data were collected for a separate study and will not be reported on, as per our a priori protocol.…”

“…Variety in recruitment sources (and their resultant conceptualisations about osteoarthritis and physical activity) was undertaken in pursuit of data triangulation [55]. Community members were invited to participate via posters, social media posts, and an email newsletter distributed by consumer advocacy body Arthritis South Australia, as well as via the recruitment list and pilot participant list of an ongoing randomised controlled trial (RCT) involving people with knee osteoarthritis [44]. The RCT pilot participants had recently completed a contemporary osteoarthritis and pain science education intervention that aimed to change conceptualisation about osteoarthritis and physical activity.…”