TY - JOUR
T1 - Self-management advice, exercise and foot orthoses for plantar heel pain
T2 - the TREADON pilot and feasibility randomised trial
AU - Chesterton, Linda S.
AU - Thomas, Martin J.
AU - Hendry, Gordon
AU - Chen, Ying
AU - Goddin, David
AU - Halliday, Nicola
AU - Lawton, Sarah A.
AU - Lewis, Martyn
AU - Mallen, Christian D.
AU - Menz, Hylton B.
AU - Foster, Nadine E.
AU - Roddy, Edward
N1 - Funding Information:
This trial was undertaken with the support of Keele Clinical Trials Unit (CTU) and the academic infrastructure and research management of the Primary Care Centre Versus Arthritis at Keele University. The authors thank all staff involved in the study, particularly Alicia Bratt, Zoe Mayson and Simon Wathall. We would like to thank participating clinicians, managerial and administrative staff at clinical sites, the NIHR Clinical Research Networks (especially Jan Wilson, research nurse) and members of the Keele Research User Group and the Trial Steering Committee. We would also like to thank Adam Garrow and the University of Manchester for permission to use the foot manikin (© The University of Manchester 2000. All rights reserved) and Versus Arthritis for permission to reproduce the exercise drawings in the Self-Management Advice Booklet.
Funding Information:
This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0614-34021). Martin J. Thomas was previously supported by an NIHR School for Primary Care Research Launching Fellowship and an Integrated Clinical Academic Programme Clinical Lectureship from the NIHR and Health Education England (HEE) (ICA-CL-2016-02-014) and is currently supported by an NIHR Development and Skills Enhancement Award (NIHR300818). Hylton B. Menz is currently a National Health and Medical Research Council of Australia Senior Research Fellow (ID: 1135995). Nadine E. Foster was supported through an NIHR Research Professorship (NIHR-RP-011-015) and is a NIHR Senior Investigator. Christian Mallen is funded by the NIHR Applied Research Collaboration West Midlands, the NIHR School for Primary Care Research and an NIHR Research Professorship in General Practice (RP-2014-04-026). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, HEE or the Department of Health and Social Care.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: 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. Methods: 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. Results: 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. Conclusions: 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. Trial registration number: ISRCTN 12160508. Prospectively registered 5th July 2016.
AB - Background: 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. Methods: 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. Results: 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. Conclusions: 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. Trial registration number: ISRCTN 12160508. Prospectively registered 5th July 2016.
KW - Exercise
KW - Foot orthoses
KW - Pilot and feasibility trial
KW - Plantar heel pain/fasciitis
KW - Randomised trial
UR - http://www.scopus.com/inward/record.url?scp=85103852832&partnerID=8YFLogxK
U2 - 10.1186/s40814-021-00808-0
DO - 10.1186/s40814-021-00808-0
M3 - Article
AN - SCOPUS:85103852832
SN - 2055-5784
VL - 7
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 92
ER -