Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain
Abstract Background There are limited evidence‐based treatment options for adolescents with patellofemoral pain (PFP). Flat, flexible footwear have been shown to reduce patellofemoral joint loading and pain in adults with PFP. The efficacy of this intervention in adolescents with PFP is not establis...
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| Format: | Article |
| Language: | English |
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Wiley
2022-01-01
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| Series: | Journal of Foot and Ankle Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13047-022-00558-z |
| _version_ | 1797321288497233920 |
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| author | Natalie Mazzella Aaron Fox Natalie Saunders Danielle Trowell Bill Vicenzino Jason Bonacci |
| author_facet | Natalie Mazzella Aaron Fox Natalie Saunders Danielle Trowell Bill Vicenzino Jason Bonacci |
| author_sort | Natalie Mazzella |
| collection | DOAJ |
| description | Abstract Background There are limited evidence‐based treatment options for adolescents with patellofemoral pain (PFP). Flat, flexible footwear have been shown to reduce patellofemoral joint loading and pain in adults with PFP. The efficacy of this intervention in adolescents with PFP is not established. The primary aim of this study is to determine the feasibility of conducting a large‐scale randomised controlled trial (RCT) of the effect of flat, flexible school footwear, when compared to traditional school footwear, in adolescents with PFP. The secondary aim is to describe changes in self‐reported outcome measures for adolescents with PFP while wearing flat, flexible footwear when compared to traditional school shoes. Methods Twenty‐four adolescents with PFP will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either (i) flat, flexible school footwear or, (ii) traditional school footwear. Participants will wear the shoe as per school requirements throughout a 12‐week intervention period. Feasibility will be assessed with (i) ≥ 75% adherence to allocated shoe wear of their total weekly school wear time, (ii) a recruitment rate of one participant per fortnight, and (iii) a dropout rate of ≤ 20%. Patient reported outcome measures will describe changes in knee pain, function, quality of life and global rating of change at 6 and 12 weeks. Descriptive statistics will be used for the primary outcomes of feasibility. Discussion This study will determine the feasibility of conducting a large scale RCT evaluating the effect of flat, flexible school shoes for adolescents with PFP. A full‐scale study will guide evidence‐based management of adolescent PFP. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12621001525875, Date registered: 9th November 2021. |
| first_indexed | 2024-03-08T04:56:21Z |
| format | Article |
| id | doaj.art-4cbc8ba2c8a34fef8bdf8e50e8b9c297 |
| institution | Directory Open Access Journal |
| issn | 1757-1146 |
| language | English |
| last_indexed | 2024-03-08T04:56:21Z |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Foot and Ankle Research |
| spelling | doaj.art-4cbc8ba2c8a34fef8bdf8e50e8b9c2972024-02-07T15:15:30ZengWileyJournal of Foot and Ankle Research1757-11462022-01-01151n/an/a10.1186/s13047-022-00558-zProtocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral painNatalie Mazzella0Aaron Fox1Natalie Saunders2Danielle Trowell3Bill Vicenzino4Jason Bonacci5Centre for Sports ResearchDeakin University3215Waurn PondsVICAustraliaCentre for Sports ResearchDeakin University3215Waurn PondsVICAustraliaCentre for Sports ResearchDeakin University3125BurwoodVICAustraliaCentre for Sports ResearchDeakin University3125BurwoodVICAustraliaSchool of Health and Rehabilitation SciencesThe University of Queensland4072St LuciaQLDAustraliaCentre for Sports ResearchDeakin University3215Waurn PondsVICAustraliaAbstract Background There are limited evidence‐based treatment options for adolescents with patellofemoral pain (PFP). Flat, flexible footwear have been shown to reduce patellofemoral joint loading and pain in adults with PFP. The efficacy of this intervention in adolescents with PFP is not established. The primary aim of this study is to determine the feasibility of conducting a large‐scale randomised controlled trial (RCT) of the effect of flat, flexible school footwear, when compared to traditional school footwear, in adolescents with PFP. The secondary aim is to describe changes in self‐reported outcome measures for adolescents with PFP while wearing flat, flexible footwear when compared to traditional school shoes. Methods Twenty‐four adolescents with PFP will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either (i) flat, flexible school footwear or, (ii) traditional school footwear. Participants will wear the shoe as per school requirements throughout a 12‐week intervention period. Feasibility will be assessed with (i) ≥ 75% adherence to allocated shoe wear of their total weekly school wear time, (ii) a recruitment rate of one participant per fortnight, and (iii) a dropout rate of ≤ 20%. Patient reported outcome measures will describe changes in knee pain, function, quality of life and global rating of change at 6 and 12 weeks. Descriptive statistics will be used for the primary outcomes of feasibility. Discussion This study will determine the feasibility of conducting a large scale RCT evaluating the effect of flat, flexible school shoes for adolescents with PFP. A full‐scale study will guide evidence‐based management of adolescent PFP. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12621001525875, Date registered: 9th November 2021.https://doi.org/10.1186/s13047-022-00558-zPatellofemoral painAdolescentsFeasibilityFootwearShoesKnee |
| spellingShingle | Natalie Mazzella Aaron Fox Natalie Saunders Danielle Trowell Bill Vicenzino Jason Bonacci Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain Journal of Foot and Ankle Research Patellofemoral pain Adolescents Feasibility Footwear Shoes Knee |
| title | Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain |
| title_full | Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain |
| title_fullStr | Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain |
| title_full_unstemmed | Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain |
| title_short | Protocol for a randomised, assessor‐blinded, parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain |
| title_sort | protocol for a randomised assessor blinded parallel group feasibility trial of flat flexible school shoes for adolescents with patellofemoral pain |
| topic | Patellofemoral pain Adolescents Feasibility Footwear Shoes Knee |
| url | https://doi.org/10.1186/s13047-022-00558-z |
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