Cargando…
The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis
INTRODUCTION: Patellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities b...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500302/ https://www.ncbi.nlm.nih.gov/pubmed/31005917 http://dx.doi.org/10.1136/bmjopen-2018-025315 |
_version_ | 1783415925347713024 |
---|---|
author | Collins, Natalie J Tan, Jade M Menz, Hylton B Russell, Trevor G Smith, Anne J Vicenzino, Bill Munteanu, Shannon E Hinman, Rana S Haines, Terry P Hart, Harvi F Patterson, Brooke E Cleary, Gearoid Donnar, Joel W Maclachlan, Liam R Crossley, Kay M |
author_facet | Collins, Natalie J Tan, Jade M Menz, Hylton B Russell, Trevor G Smith, Anne J Vicenzino, Bill Munteanu, Shannon E Hinman, Rana S Haines, Terry P Hart, Harvi F Patterson, Brooke E Cleary, Gearoid Donnar, Joel W Maclachlan, Liam R Crossley, Kay M |
author_sort | Collins, Natalie J |
collection | PubMed |
description | INTRODUCTION: Patellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity. METHODS AND ANALYSIS: The FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses. ETHICS AND DISSEMINATION: Ethical approval has been granted by La Trobe University’s Human Ethics Committee and The University of Queensland’s Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources. TRIAL REGISTRATION NUMBER: ANZCTRN12617000385347; Pre-results. |
format | Online Article Text |
id | pubmed-6500302 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-65003022019-05-21 The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis Collins, Natalie J Tan, Jade M Menz, Hylton B Russell, Trevor G Smith, Anne J Vicenzino, Bill Munteanu, Shannon E Hinman, Rana S Haines, Terry P Hart, Harvi F Patterson, Brooke E Cleary, Gearoid Donnar, Joel W Maclachlan, Liam R Crossley, Kay M BMJ Open Rheumatology INTRODUCTION: Patellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity. METHODS AND ANALYSIS: The FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses. ETHICS AND DISSEMINATION: Ethical approval has been granted by La Trobe University’s Human Ethics Committee and The University of Queensland’s Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources. TRIAL REGISTRATION NUMBER: ANZCTRN12617000385347; Pre-results. BMJ Publishing Group 2019-04-20 /pmc/articles/PMC6500302/ /pubmed/31005917 http://dx.doi.org/10.1136/bmjopen-2018-025315 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Rheumatology Collins, Natalie J Tan, Jade M Menz, Hylton B Russell, Trevor G Smith, Anne J Vicenzino, Bill Munteanu, Shannon E Hinman, Rana S Haines, Terry P Hart, Harvi F Patterson, Brooke E Cleary, Gearoid Donnar, Joel W Maclachlan, Liam R Crossley, Kay M The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
title | The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
title_full | The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
title_fullStr | The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
title_full_unstemmed | The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
title_short | The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
title_sort | footpath study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis |
topic | Rheumatology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500302/ https://www.ncbi.nlm.nih.gov/pubmed/31005917 http://dx.doi.org/10.1136/bmjopen-2018-025315 |
work_keys_str_mv | AT collinsnataliej thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT tanjadem thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT menzhyltonb thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT russelltrevorg thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT smithannej thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT vicenzinobill thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT munteanushannone thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT hinmanranas thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT hainesterryp thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT hartharvif thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT pattersonbrookee thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT clearygearoid thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT donnarjoelw thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT maclachlanliamr thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT crossleykaym thefootpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT collinsnataliej footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT tanjadem footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT menzhyltonb footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT russelltrevorg footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT smithannej footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT vicenzinobill footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT munteanushannone footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT hinmanranas footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT hainesterryp footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT hartharvif footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT pattersonbrookee footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT clearygearoid footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT donnarjoelw footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT maclachlanliamr footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis AT crossleykaym footpathstudyprotocolforamulticentreparticipantandassessorblindparallelgrouprandomisedclinicaltrialoffootorthosesforpatellofemoralosteoarthritis |