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
Abstract
BACKGROUND

Running is a hugely popular sport. Unfortunately, running-related injury (RRI) rates are high, particularly amongst amateur and recreational runners. Finding ways to reduce RRI rates and maximise comfort and performance for runners is important. Evidence regarding whether orthotics can successfully improve these parameters is limited and contradicting. Further research is required to provide runners with clearer guidance on the usefulness of orthotics.

AIM

To investigate the effect of Aetrex Orthotics on comfort, speed and RRI rates during recreational running.

METHODS

One hundred and six recreational runners were recruited on a voluntary basis via running clubs and social media pages and randomised into either the intervention or control group. Participants in the intervention group ran with Aetrex L700 Speed Orthotics inserted in their usual running shoes, whilst participants in the control group ran in their usual running shoes with no orthotics. The study ran for an 8-wk period. Participants provided data relating to running comfort, distance, and time during weeks 3-6. Participants provided data relating to any RRIs they sustained during all 8 wks. Running distance and time were used to calculate running speed in miles per hour (mph). For each outcome variable, 95% confidence intervals and P values were calculated to assess the statistical significance between the groups. For comfort and speed data, univariate multi-level analysis was performed, and for outcome variables with significant between group differences, multi-level multivariate analysis was performed to evaluate any confounding effects of gender and age.

RESULTS

Ninety-four participants were included in the final analysis (drop-out rate = 11%). Comfort and speed from 940 runs and 978 injury data reports were analysed. Participants who ran with orthotics reported, on average, speeds 0.30 mph faster (P = 0.20) and comfort scores 1.27 points higher (P ≤ 0.001) than participants who ran with no orthotics. They were also 2.22 times less likely to sustain an injury (P = 0.08) than participants who ran with no orthotics. However, findings were only significant for comfort and not for speed or injury rates. Age and gender were found to be significant predictors of comfort. However, the improvements in comfort reported by participants who ran with orthotics were still significant after adjusting for age and gender.

CONCLUSION

This study found orthotics to improve comfort and speed and prevent RRIs whilst running. However, these findings were only statistically significant for comfort.

Keywords: Running; Foot orthoses; Running related injuries; Pain; Patient comfort; Athletic performance.

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.