Randomized Controlled Trial
Copyright ©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
Does orthotics use improve comfort, speed and injury rate during running? Preliminary analysis of a randomised control trial
Alice E Fortune, Jonathan M G Sims, Samantha J Rhodes, George Ampat
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
ARTICLE HIGHLIGHTS
Research background

There is currently mixed and limited evidence regarding the effectiveness of orthotics use in increasing comfort and speed and reducing injury rate during running.

Research motivation

Further research into the effect of orthotics use on running-related injury (RRI) rates would be helpful for the ever-growing population of runners, who frequently suffer from RRIs. Additionally, there is a need to clarify whether orthotics use increases comfort during running and helps improve running speed.

Research objectives

To investigate whether running with Aetrex Orthotics improves comfort and performance and reduces injury whilst running.

Research methods

A randomised control trial study design was used. Participants were regular runners over 18 with no serious health conditions, ongoing foot pain or deformity, previous foot surgery in their lifetime or any surgery in the past 6 months, recruited on a voluntary basis through local running clubs and social media advertisements. Participants were randomly assigned to either an intervention group or a control group. Participants in the intervention group ran with Aetrex orthotics inserted into their normal running shoes, whilst participants in the control group ran in their normal running shoes with no orthotics. All participants were asked to complete runs as they usually would and provide data regarding comfort during running, running time and distance, and any RRIs over an 8-wk study period. For each outcome variable, the mean for each group, effect size and 95% confidence interval were calculated, and a t-test was performed to determine if between-group differences were statistically significant.

Research results

This article presents the interim results from the first 47 participants recruited to this study (intervention group = 23, control group = 24), who provided data for all three primary outcomes from a total of 543 runs. Participants in the intervention group reported higher comfort scores (8.00 ± 1.41 vs 6.96 ± 2.03, P ≤ 0.0001), faster running speeds (6.27 ± 1.03 vs 6.00 ± 1.54, P = 0.013), and lower RRI rates (0.70 ± 1.01 vs 1.21 ± 1.53, P = 0.18) than participants in the control group. Statistical significance was considered if P < 0.05. The findings were statistically significant for comfort and running speed but not for RRI rate.

Research conclusions

This interim report finds that using Aetrex Orthotics whilst running significantly increases comfort and speed. Using Aetrex Orthotics also reduces the rate of RRIs. However, this was not significant.

Research perspectives

Further analysis, once recruitment and data collection in this study is complete, is needed to expand on the findings given in this report and provide a full analysis of the cost-benefit of using orthotics for running.