Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study

Abstract Background Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifia...

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Main Authors: Melinda M. Franettovich Smith, Natalie J. Collins, Rebecca Mellor, Alison Grimaldi, James Elliott, Mark Hoggarth, Kenneth A. Weber II, Bill Vicenzino
Format: Article
Language:English
Published: BMC 2020-05-01
Series:Journal of Foot and Ankle Research
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13047-020-00384-1
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author Melinda M. Franettovich Smith
Natalie J. Collins
Rebecca Mellor
Alison Grimaldi
James Elliott
Mark Hoggarth
Kenneth A. Weber II
Bill Vicenzino
author_facet Melinda M. Franettovich Smith
Natalie J. Collins
Rebecca Mellor
Alison Grimaldi
James Elliott
Mark Hoggarth
Kenneth A. Weber II
Bill Vicenzino
author_sort Melinda M. Franettovich Smith
collection DOAJ
description Abstract Background Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP. Methods Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance. Discussion To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT. Trial registration The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry ( ACTRN12619000987167 ) on 11th July 2019.
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spelling doaj.art-e83f63a338d5461b912656e02edef3992024-02-03T00:03:22ZengBMCJournal of Foot and Ankle Research1757-11462020-05-0113111410.1186/s13047-020-00384-1Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility studyMelinda M. Franettovich Smith0Natalie J. Collins1Rebecca Mellor2Alison Grimaldi3James Elliott4Mark Hoggarth5Kenneth A. Weber II6Bill Vicenzino7School of Health and Rehabilitation Sciences, The University of QueenslandSchool of Health and Rehabilitation Sciences, The University of QueenslandSchool of Health and Rehabilitation Sciences, The University of QueenslandSchool of Health and Rehabilitation Sciences, The University of QueenslandFaculty of Medicine and Health and The Kolling Research Institute, The University of SydneyDepartment of Physical Therapy and Human Movement Sciences, Northwestern UniversitySystems Neuroscience and Pain Lab, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of MedicineSchool of Health and Rehabilitation Sciences, The University of QueenslandAbstract Background Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP. Methods Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance. Discussion To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT. Trial registration The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry ( ACTRN12619000987167 ) on 11th July 2019.http://link.springer.com/article/10.1186/s13047-020-00384-1Plantar fasciitisExercise therapyRehabilitationIntrinsic foot musclesPhysiotherapyRandomised control trial
spellingShingle Melinda M. Franettovich Smith
Natalie J. Collins
Rebecca Mellor
Alison Grimaldi
James Elliott
Mark Hoggarth
Kenneth A. Weber II
Bill Vicenzino
Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
Journal of Foot and Ankle Research
Plantar fasciitis
Exercise therapy
Rehabilitation
Intrinsic foot muscles
Physiotherapy
Randomised control trial
title Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
title_full Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
title_fullStr Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
title_full_unstemmed Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
title_short Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study
title_sort foot exercise plus education versus wait and see for the treatment of plantar heel pain feet trial a protocol for a feasibility study
topic Plantar fasciitis
Exercise therapy
Rehabilitation
Intrinsic foot muscles
Physiotherapy
Randomised control trial
url http://link.springer.com/article/10.1186/s13047-020-00384-1
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