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

Plantar fasciitis (PF) affects around 10% of the population. Prefabricated orthotics with arch support has been shown to provide symptom relief in PF by decreasing the repetitive stress sustained by the plantar fascia. However, prefabricated orthotics are only effective when shoes are worn, meaning the foot may be left unsupported when it is impractical to wear shoes. Using orthotic sandals in conjunction with prefabricated orthotics may increase PF symptom relief, as they can be worn inside the home, extending the period in which the foot is supported.


To compare the combined use of prefabricated orthotics and orthotic sandals vs the sole use of prefabricated orthotics in the treatment of PF.


98 participants with PF were randomised into two groups. The intervention group received the Aetrex L420 Compete orthotics and the Aetrex L3000 Maui Flips (orthotic sandals), whilst the control group received the Aetrex L420 Compete orthotics only. Foot pain was assessed both by the numerical rating scale (NRS) and the pain sub-scale of the foot health status questionnaire (FHSQ). Foot functionality was measured using the function sub-scale of the FHSQ. Symptom change was measured using the global rating of change scale (GROC).


Foot pain scores measured both by NRS and FHSQ pain sub-scale showed statistically significant reductions in foot pain in both groups (P < 0.05) at six months. Both groups also reported statistically significant improvements (P < 0.05) in function as measured by the FHSQ function subscale and improvement of symptoms as measured by the GROC scale. Between-group analysis showed that the intervention group with the combined use of orthotics and orthotic sandals scored better on all four outcome measures as compared to the control group with the sole use of orthotics. However, the between-group analysis only reached statistical significance on the NRS pain score (P < 0.05).


Combined use of prefabricated orthotics and orthotic sandals provides a greater decrease in foot pain and improvement in foot function in PF compared to using prefabricated orthotics alone.

Keywords: Plantar fasciitis, Foot diseases, Musculoskeletal pain, Foot orthoses

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.