Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Sep 18, 2023; 14(9): 707-719
Published online Sep 18, 2023. doi: 10.5312/wjo.v14.i9.707
Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial
Portia Amoako-Tawiah, Holly Love, Jaida Chacko Madathilethu, Jessica LaCourse, Alice E Fortune, Jonathan M G Sims, George Ampat
Portia Amoako-Tawiah, Holly Love, Jessica LaCourse, Alice E Fortune, George Ampat, School of Medicine, University of Liverpool, Merseyside, Liverpool L69 3GE, United Kingdom
Jaida Chacko Madathilethu, Urology, Royal Stoke University Hospital, Staffordshire, Stoke ST4 6QG, United Kingdom
Jonathan M G Sims, George Ampat, Research Unit, Talita Cumi Ltd., Merseyside, Southport PR8 3NS, United Kingdom
Author contributions: Ampat G supervises the research team and acquired the funding; Ampat G and Sims JMG conceptualised the study and were involved in protocol development and gaining ethical approval; Ampat G and Sims JMG were involved in participant recruitment and data acquisition; Amoako-Tawiah P, Love H, Chacko Madathilethu J, LaCourse J, Fortune AE, and Sims JMG wrote the manuscript; All authors reviewed and edited the manuscript and approved the final draft.
Supported by Aetrex, Inc. 414 Alfred Avenue Teaneck, NJ 07666, United States.
Institutional review board statement: The study was reviewed and approved by the Wales Research Ethics Committee 5.
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: George Ampat and Jonathan M G Sims are employees of Talita Cumi Ltd, which has a commercial relationship with Aetrex Worldwide, Inc. 414 Alfred Avenue Teaneck, NJ 07666, United States. All other authors have no conflict of interest to declare.
Data sharing statement: No additional data are available.
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:
Corresponding author: George Ampat, FRCS, FRCS (Gen Surg), MBBS, Consultant Physician-Scientist, Doctor, Lecturer, School of Medicine, University of Liverpool, Cedar House, Ashton St, Merseyside, Liverpool L69 3GE, United Kingdom.
Received: April 13, 2023
Peer-review started: April 13, 2023
First decision: July 4, 2023
Revised: August 3, 2023
Accepted: August 21, 2023
Article in press: August 21, 2023
Published online: September 18, 2023
Core Tip

Core Tip: Plantar fasciitis (PF) is a common cause of heel pain and affects 10% of the population. Prefabricated orthotics provides relief of symptoms by supporting the arch but can only be used with shoes. Using both prefabricated orthotics and orthotic sandals can extend the period of support. This study finds that the combined use of Aetrex L420 orthotics and Aetrex L3000 orthotic sandals and the sole use of Aetrex L420 orthotics provide statistically significant decreases in foot pain and improved foot function in PF. The effect was greater when both the orthotic and orthotic sandals were used in combination.