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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. May 18, 2023; 14(5): 348-361
Published online May 18, 2023. doi: 10.5312/wjo.v14.i5.348
Published online May 18, 2023. doi: 10.5312/wjo.v14.i5.348
Does orthotics use improve comfort, speed, and injury rate during running? A randomised control trial
Alice E Fortune, School of Medicine, University of Liverpool, Liverpool L69 3GE, United Kingdom
Jonathan M G Sims, Research Unit, Talita Cumi Ltd., Southport, PR8 3NS, United Kingdom
George Ampat, School of Medicine, University of Liverpool, Liverpool L69 3GE, Merseyside, United Kingdom
Author contributions: Fortune AE, Sims JMG, and Ampat G designed the research study; Sims JMG was involved in recruitment and data collection; Ampat G performed telephone consultations with all participants on enrolment to the study; Fortune AE and Sims JMG analysed the data. Fortune AE, Sims JMG and Ampat G wrote the manuscript; All authors have read and approved the final manuscript.
Supported by Aetrex , Inc. 414 Alfred Avenue Teaneck, NJ 07666, USA.
Institutional review board statement: This study was reviewed and approved by Wales Research Committee 5 (Approval No. 21/WA/0098).
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov/ct2/show/NCT04901442. The registration identification number is: NCT04901442.
Informed consent statement: All study participants gave their informed, written consent (via an online e-form) prior to study inclusion.
Conflict-of-interest statement: George Ampat and Jonathan M G Sims are Directors/employees of Talita Cumi Ltd. Talita Cumi Ltd has a commercial relationship with Aetrex, Inc. 414 Alfred Avenue Teaneck, NJ 07666, USA. Alice E Fortune has no conflict of interest.
Data sharing statement: The anonymised dataset is available from the corresponding author at g.ampat@liverpool.ac.uk. Participants gave informed consent for sharing of anonymised data.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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 and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: George Ampat, FRCS, FRCS (Gen Surg), MBBS, Consultant Physician-Scientist, Doctor, Lecturer, School of Medicine, University of Liverpool, Cedar House, Ashton Street, Liverpool L69 3GE, Merseyside, United Kingdom. geampat@gmail.com
Received: November 28, 2022
Peer-review started: November 28, 2022
First decision: January 20, 2023
Revised: February 2, 2023
Accepted: April 6, 2023
Article in press: April 6, 2023
Published online: May 18, 2023
Processing time: 170 Days and 21.8 Hours
Peer-review started: November 28, 2022
First decision: January 20, 2023
Revised: February 2, 2023
Accepted: April 6, 2023
Article in press: April 6, 2023
Published online: May 18, 2023
Processing time: 170 Days and 21.8 Hours
Core Tip
Core Tip: Running-related injuries are common, necessitating research into ways to prevent injury. Foot orthotics have been suggested as a method to reduce running-related injury rates and improve comfort and performance, which are important components of running. Previous evidence regarding this is limited and mixed. This randomised control trial finds that running with Aetrex L700 Speed Orthotics inserted into normal running shoes reduces the rate of running-related injuries and improves both comfort and speed. These findings were only statistically significant for comfort. Providing increased comfort may encourage individuals to take up running, improving their health and decreasing the demand on healthcare systems.