Chesterton, LS, Thomas, MJ ORCID: https://orcid.org/0000-0002-4951-9925, Hendry, G, Chen, Y ORCID: https://orcid.org/0000-0002-5919-743X, Goddin, D, Halliday, N, Lawton, SA ORCID: https://orcid.org/0000-0002-8909-2057, Lewis, M ORCID: https://orcid.org/0000-0002-3667-132X, Mallen, CD ORCID: https://orcid.org/0000-0002-2677-1028, Menz, HB, Foster, NE ORCID: https://orcid.org/0000-0003-4429-9756 and Roddy, E ORCID: https://orcid.org/0000-0002-8954-7082 (2021) Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial. Pilot and Feasibility Studies, 7 (1).

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Abstract

Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64–100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5–0.6, 0.4 and < 0.3, respectively.We demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. ISRCTN 12160508. Prospectively registered 5 July 2016.

Item Type: Article
Additional Information: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Uncontrolled Keywords: Randomised trial; Pilot and feasibility trial; Plantar heel pain/fasciitis; Foot orthoses; Exercise
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
Divisions: Faculty of Medicine and Health Sciences > Primary Care Health Sciences
Depositing User: Symplectic
Date Deposited: 08 Apr 2021 09:11
Last Modified: 29 Apr 2021 15:36
URI: https://eprints.keele.ac.uk/id/eprint/9346

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