Clinical Trials Study
Copyright ©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
Does orthotics use improve comfort, speed, and injury rate during running? A randomised control trial
Alice E Fortune, Jonathan M G Sims, George Ampat
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
ARTICLE HIGHLIGHTS
Research background

Current evidence regarding the effect of orthotics on comfort, speed and injuries during running is limited and mixed.

Research motivation

Running is a highly popular sport; however, the rate of running-related injuries is high. Exploring the ability of orthotics to reduce injury and improve speed and comfort during running would be valuable to runners and, if the results are positive, encourage individuals to take up running, thereby improving their health.

Research objectives

To explore whether running with Aetrex[26] Orthotics inserted into normal running shoes reduces the rate of running-related injuries and improves comfort and speed.

Research methods

In this randomised control trial, participants were recruited on a voluntary basis and allocated to either the intervention (orthotic) group or the control (no orthotic) group. Participants in the intervention group were asked to run with a pair of Aetrex[26] L700 Speed Orthotics inserted into their normal running shoes, whilst participants in the control group were asked to run in their normal running shoes with no orthotics. Data for any related running-related injuries was collected over an 8-wk period. Comfort scores and run duration and distance data were collected immediately after any run performed during weeks 3-6. Univariate multi-level analysis was performed for comfort and speed data. Odds ratios were calculated for injury data, and 95% confidence intervals and P values were calculated for all three outcomes. Multilevel multivariate analysis was performed for outcomes with significant findings between groups to evaluate any confounding effects of gender and age.

Research results

Data from 94 participants were included in the final analysis. On average, participants in the intervention (orthotic) group reported higher comfort scores, faster running speeds and fewer injuries. This data was significant for comfort but not for injury rates or running speed. Gender and age were found to significantly affect comfort, but significant improvements in comfort when wearing the orthotic were still present after adjusting for gender and age.

Research conclusions

This study provides evidence that running with prefabricated orthotics inserted into normal running shoes increases comfort and speed and reduces the rate of running-related injuries. However, data were only significant for comfort and not for speed or injury rates.

Research perspectives

Further research on this subject is required due to the ongoing need to find a cost-effective way to reduce injury rates in recreational runners and encourage individuals to take up running to improve their health. Future studies should consider collecting data regarding the tendency for running injury and usual running speeds to allow adjustment of results for these confounding variables.