Cargando…

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

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 be...

Descripción completa

Detalles Bibliográficos
Autores principales: Stanton, Tasha R., Braithwaite, Felicity A., Butler, David, Moseley, G. Lorimer, Hill, Catherine, Milte, Rachel, Ratcliffe, Julie, Maher, Carol, Tomkins-Lane, Christy, Pulling, Brian W., MacIntyre, Erin, Esterman, Adrian, Stanford, Ty, Lee, Hopin, Fraysse, Francois, Metcalf, Ben, Mouatt, Brendan, Bennell, Kim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8401372/
https://www.ncbi.nlm.nih.gov/pubmed/34454458
http://dx.doi.org/10.1186/s12891-021-04561-6
_version_ 1783745534618501120
author Stanton, Tasha R.
Braithwaite, Felicity A.
Butler, David
Moseley, G. Lorimer
Hill, Catherine
Milte, Rachel
Ratcliffe, Julie
Maher, Carol
Tomkins-Lane, Christy
Pulling, Brian W.
MacIntyre, Erin
Esterman, Adrian
Stanford, Ty
Lee, Hopin
Fraysse, Francois
Metcalf, Ben
Mouatt, Brendan
Bennell, Kim
author_facet Stanton, Tasha R.
Braithwaite, Felicity A.
Butler, David
Moseley, G. Lorimer
Hill, Catherine
Milte, Rachel
Ratcliffe, Julie
Maher, Carol
Tomkins-Lane, Christy
Pulling, Brian W.
MacIntyre, Erin
Esterman, Adrian
Stanford, Ty
Lee, Hopin
Fraysse, Francois
Metcalf, Ben
Mouatt, Brendan
Bennell, Kim
author_sort Stanton, Tasha R.
collection PubMed
description 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). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-021-04561-6.
format Online
Article
Text
id pubmed-8401372
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-84013722021-08-30 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 Stanton, Tasha R. Braithwaite, Felicity A. Butler, David Moseley, G. Lorimer Hill, Catherine Milte, Rachel Ratcliffe, Julie Maher, Carol Tomkins-Lane, Christy Pulling, Brian W. MacIntyre, Erin Esterman, Adrian Stanford, Ty Lee, Hopin Fraysse, Francois Metcalf, Ben Mouatt, Brendan Bennell, Kim BMC Musculoskelet Disord Study Protocol 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). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-021-04561-6. BioMed Central 2021-08-28 /pmc/articles/PMC8401372/ /pubmed/34454458 http://dx.doi.org/10.1186/s12891-021-04561-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Stanton, Tasha R.
Braithwaite, Felicity A.
Butler, David
Moseley, G. Lorimer
Hill, Catherine
Milte, Rachel
Ratcliffe, Julie
Maher, Carol
Tomkins-Lane, Christy
Pulling, Brian W.
MacIntyre, Erin
Esterman, Adrian
Stanford, Ty
Lee, Hopin
Fraysse, Francois
Metcalf, Ben
Mouatt, Brendan
Bennell, Kim
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8401372/
https://www.ncbi.nlm.nih.gov/pubmed/34454458
http://dx.doi.org/10.1186/s12891-021-04561-6
work_keys_str_mv AT stantontashar theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT braithwaitefelicitya theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT butlerdavid theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT moseleyglorimer theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT hillcatherine theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT milterachel theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT ratcliffejulie theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT mahercarol theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT tomkinslanechristy theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT pullingbrianw theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT macintyreerin theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT estermanadrian theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT stanfordty theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT leehopin theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT frayssefrancois theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT metcalfben theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT mouattbrendan theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT bennellkim theepiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT stantontashar epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT braithwaitefelicitya epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT butlerdavid epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT moseleyglorimer epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT hillcatherine epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT milterachel epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT ratcliffejulie epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT mahercarol epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT tomkinslanechristy epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT pullingbrianw epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT macintyreerin epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT estermanadrian epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT stanfordty epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT leehopin epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT frayssefrancois epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT metcalfben epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT mouattbrendan epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis
AT bennellkim epiphakneetrialexplainingpaintotargetunhelpfulpainbeliefstoincreasephysicalactivityinkneeosteoarthritisaprotocolforamulticentrerandomisedcontrolledtrialwithclinicalandcosteffectivenessanalysis