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.

Autor: Stanton TR; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia. tasha.stanton@unisa.edu.au., Braithwaite FA; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia., Butler D; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia.; NOIgroup Pty Ltd, Adelaide, South Australia., Moseley GL; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia., Hill C; Rheumatology Department, The Queen Elizabeth Hospital, Adelaide, Australia.; Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, Australia., Milte R; Caring Futures Institute, Flinders University, Adelaide, Australia., Ratcliffe J; Caring Futures Institute, Flinders University, Adelaide, Australia., Maher C; Alliance for Research in Exercise, Nutrition and Activity (ARENA), Allied Health and Human Performance, University of South Australia, Adelaide, Australia., Tomkins-Lane C; Department of Health and Physical Education, Mount Royal University, Calgary, Canada., Pulling BW; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia., MacIntyre E; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia., Esterman A; Clinical & Health Sciences, University of South Australia, Adelaide, Australia., Stanford T; Clinical & Health Sciences, University of South Australia, Adelaide, Australia., Lee H; Centre for Statistics in Medicine, Rehabilitation Research in Oxford (RRIO), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.; School of Medicine and Public Health, University of Newcastle, Newcastle, Australia., Fraysse F; Alliance for Research in Exercise, Nutrition and Activity (ARENA), Allied Health and Human Performance, University of South Australia, Adelaide, Australia., Metcalf B; Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Victoria, Australia., Mouatt B; IIMPACT in Health, Allied Health and Human Performance, University of South Australia, G.P.O. Box 2471, Adelaide, 5001, Australia., Bennell K; Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Victoria, Australia.
Jazyk: angličtina
Zdroj: BMC musculoskeletal disorders [BMC Musculoskelet Disord] 2021 Aug 28; Vol. 22 (1), pp. 738. Date of Electronic Publication: 2021 Aug 28.
DOI: 10.1186/s12891-021-04561-6
Abstrakt: 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).
(© 2021. The Author(s).)
Databáze: MEDLINE
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