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

Tasha R Stanton, Felicity A Braithwaite, David Butler, G Lorimer Moseley, Catherine Hill, Rachel Milte, Julie Ratcliffe, Carol Maher, Christy Tomkins-Lane, Brian W Pulling, Erin MacIntyre, Adrian Esterman, Ty Stanford, Hopin Lee, Francois Fraysse, Ben Metcalf, Brendan Mouatt, Kim Bennell, Tasha R Stanton, Felicity A Braithwaite, David Butler, G Lorimer Moseley, Catherine Hill, Rachel Milte, Julie Ratcliffe, Carol Maher, Christy Tomkins-Lane, Brian W Pulling, Erin MacIntyre, Adrian Esterman, Ty Stanford, Hopin Lee, Francois Fraysse, Ben Metcalf, Brendan Mouatt, Kim Bennell

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).

Keywords: Exercise; Osteoarthritis; Pain science education; Physical activity; Physiotherapy; RCT; Strengthening program; Walking program.

Conflict of interest statement

TRS receives payment for lectures on pain and rehabilitation. TRS, DB, and GLM are authors of the Explain Pain Osteoarthritis Handbook and will receive royalties from sales should it progress to market. GLM and DB receive author royalties for other related books on pain and rehabilitation. GLM has received support from Reality Health, ConnectHealth, sporting organisations and various workers’ compensation and income protection insurers for work related to pain education and rehabilitation and has received payment for lectures on pain and rehabilitation. FAB has received speaker fees for providing lectures related to pain and blinding in clinical trials. BWP has received honoraria from Elsevier for contributing to a textbook on geriatric physical therapy. BM receives remuneration from The Knowledge Exchange for provision of continuing professional development workshops related to pain and exercise rehabilitation. KB received payments from Wolters Kluwer for UpToDate clinical OA guidelines.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Participant flow through the randomised controlled trial
Fig. 2
Fig. 2
Study procedures and timing of outcome assessments. NRS = Numeric Rating Scale; Rx = in-person treatment session; TH = Telehealth (Telephone call or videoconferencing); Wk = Week; PSE = Pain Science Education; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index

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Source: PubMed

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