Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial
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.
: 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 St, Merseyside, Liverpool L69 3GE, United Kingdom. firstname.lastname@example.org
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