Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial
Abstract Background This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoart...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1936-1 |
| _version_ | 1818201950623105024 |
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| author | Shannon E. Munteanu Karl B. Landorf Jodie A. McClelland Edward Roddy Flavia M. Cicuttini Alan Shiell Maria Auhl Jamie J. Allan Andrew K. Buldt Hylton B. Menz |
| author_facet | Shannon E. Munteanu Karl B. Landorf Jodie A. McClelland Edward Roddy Flavia M. Cicuttini Alan Shiell Maria Auhl Jamie J. Allan Andrew K. Buldt Hylton B. Menz |
| author_sort | Shannon E. Munteanu |
| collection | DOAJ |
| description | Abstract Background This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA). Methods Ninety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model. Discussion This study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts. Trial registration Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482 . Registered on 28 April 2016. |
| first_indexed | 2024-12-12T03:01:42Z |
| format | Article |
| id | doaj.art-c9f9602a39434c2baad88cddc4374c5f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T03:01:42Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c9f9602a39434c2baad88cddc4374c5f2022-12-22T00:40:37ZengBMCTrials1745-62152017-04-0118111310.1186/s13063-017-1936-1Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trialShannon E. Munteanu0Karl B. Landorf1Jodie A. McClelland2Edward Roddy3Flavia M. Cicuttini4Alan Shiell5Maria Auhl6Jamie J. Allan7Andrew K. Buldt8Hylton B. Menz9Discipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele UniversityDepartment of Epidemiology and Preventive Medicine, Monash University, Alfred HospitalDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityDiscipline of Podiatry, School of Allied Health, College of Science, Health and Engineering, La Trobe UniversityAbstract Background This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA). Methods Ninety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model. Discussion This study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts. Trial registration Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482 . Registered on 28 April 2016.http://link.springer.com/article/10.1186/s13063-017-1936-1OsteoarthritisMetatarsophalangeal jointHallux rigidusFoot orthoses |
| spellingShingle | Shannon E. Munteanu Karl B. Landorf Jodie A. McClelland Edward Roddy Flavia M. Cicuttini Alan Shiell Maria Auhl Jamie J. Allan Andrew K. Buldt Hylton B. Menz Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial Trials Osteoarthritis Metatarsophalangeal joint Hallux rigidus Foot orthoses |
| title | Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial |
| title_full | Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial |
| title_fullStr | Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial |
| title_full_unstemmed | Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial |
| title_short | Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial |
| title_sort | shoe stiffening inserts for first metatarsophalangeal joint osteoarthritis the simple trial study protocol for a randomised controlled trial |
| topic | Osteoarthritis Metatarsophalangeal joint Hallux rigidus Foot orthoses |
| url | http://link.springer.com/article/10.1186/s13063-017-1936-1 |
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