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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Jul 18, 2022; 13(7): 652-661
Published online Jul 18, 2022. doi: 10.5312/wjo.v13.i7.652
Published online Jul 18, 2022. doi: 10.5312/wjo.v13.i7.652
Does orthotics use improve comfort, speed and injury rate during running? Preliminary analysis of a randomised control trial
Alice E Fortune, George Ampat, School of Medicine, University of Liverpool, Liverpool L69 3GE, United Kingdom
Jonathan M G Sims, Samantha J Rhodes, Research Unit, Talita Cumi Ltd, Southport PR8 3NS, United Kingdom
Author contributions: Fortune AE, Sims JMG, Rhodes SJ, and Ampat G contributed equally to the study; Fortune AE, Sims JMG and Ampat G designed the research study; Sims JMG and Rhodes SJ were involved in recruitment and data collection; Ampat G performed telephone consultations with all participants on enrolment to the study; Fortune AE analysed the data and 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 (reference number: 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, Jonathan M G Sims and Samantha J Rhodes 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, MBBS, MS, Surgeon, School of Medicine, University of Liverpool, Cedar House, Ashton Street, Liverpool L69 3GE, United Kingdom. geampat@liverpool.ac.uk
Received: March 6, 2022
Peer-review started: March 6, 2022
First decision: April 28, 2022
Revised: May 13, 2022
Accepted: June 24, 2022
Article in press: June 24, 2022
Published online: July 18, 2022
Processing time: 133 Days and 16.6 Hours
Peer-review started: March 6, 2022
First decision: April 28, 2022
Revised: May 13, 2022
Accepted: June 24, 2022
Article in press: June 24, 2022
Published online: July 18, 2022
Processing time: 133 Days and 16.6 Hours
Core Tip
Core Tip: Running-related injuries are becoming increasingly prevalent due to the increasing popularity of this sport. Foot orthotics have been suggested to increase comfort and speed whilst running, as well as reduce injury rate. However, current evidence is limited and mixed. This article, presenting preliminary randomised control trial data, finds significant evidence that running with Aetrex L700 Speed Orthotics, compared to running with no orthotics, in 'participants' regular running shoes, improves comfort and running speed. Participants running with Aetrex L700 Speed Orthotics, on average, reported lower injury rates than those running without orthotics. However, this difference was not significant.