Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: protocol for the TREADON randomised multi-arm multi-stage adaptive trial

Thomas, Martin J; Hughes, Gemma; Cooke, Kendra; Butler-Walley, Stephanie; Marshall, Emma; Bowyer, Laura; Wathall, Simon; Smith, Jo; Lawton, Sarah A; Brammar, June; Burnett, Thomas; Drake, Chris; Foster, Nadine E; Hendry, Gordon J; Holden, Melaine A; Jaki, Thomas; Joseph, Royes; Keenan, Anne-Maree; Kigozi, Jesse; Lewis, Martyn; Mallen, Christian D; Menz, Hylton B; Mozgunov, Pavel; Roddy, Edward

Abstract

Background
Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP.

Objectives
To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP.

Methods
A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1–12, monthly during months 4–12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0–10 numeric rating scale) between baseline and the average over 6–12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1–12, ii) pain at 6 and 12 months, and monthly from 3–12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout.

Discussion
The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP.

Citation

Thomas, M. J., Hughes, G., Cooke, K., Butler-Walley, S., Marshall, E., Bowyer, L., Wathall, S., Smith, J., Lawton, S. A., Brammar, J., Burnett, T., Drake, C., Foster, N. E., Hendry, G. J., Holden, M. A., Jaki, T., Joseph, R., Keenan, A.-M., Kigozi, J., Lewis, M., …Roddy, E. (2025). Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: protocol for the TREADON randomised multi-arm multi-stage adaptive trial

• Other Type: Protocol
• Acceptance Date: May 6, 2025
• Online Publication Date: May 6, 2025
• Publication Date: May 6, 2025
• Deposit Date: May 8, 2025
• Publicly Available Date: May 8, 2025
• Pages: 42
• DOI: https://doi.org/10.3310/nihropenres.13930.1
• Public URL: https://keele-repository.worktribe.com/output/1232055
• Publisher URL: https://openresearch.nihr.ac.uk/articles/5-42/v1
• Additional Information: Referee status: Awaiting Peer Review; Grant Information: This project is funded by the National Institute for Health and Care Research (NIHR) under its Health Technology Assessment Programme (NIHR131638).; The views expressed in this manuscript are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). TJ and PM received funding from the UK Medical Research Council (MC_UU 00002/14, MC UU 00002/19 and MC UU 00040/03). PM is also funded by the NIHR (Advanced Fellowship, NIHR300576). CDM is funded by the NIHR Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research. The funder and trial sponsor had no role in the trial design, data collection and analysis plans, manuscript preparation or decision to submit for publication. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.; Copyright: This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.