Title: Clinical and cost-effectiveness of individualised exercises and foot orthoses in the treatment of plantar heel pain: a randomised multi-arm multi-stage (MAMS) adaptive trial (TReatments of Exercise AnD Orthotics for plaNtar heel pain (TREADON))
Funder: Department of Health and Social Care

Abstract: Aim(s) of the research: To show whether exercises and/or foot orthoses (shoe insoles) provide more pain relief for adults with plantar heel pain than a self-management advice booklet alone, and whether this is good value for money for the NHS._x000D_ _x000D_ Background: Pain under the heel (called plantar heel pain, PHP) is a common condition affecting 1 in 10 adults during their lifetime. It makes walking and completing everyday tasks, including going to work, difficult. Most patients who consult in general practice are given pain medication and advice yet the problem often continues. In our successful pilot and feasibility trial, foot orthoses and exercises showed promise for improving pain and function but a large, high-quality main trial is needed to confirm this._x000D_ _x000D_ Design and Methods: In this randomised controlled trial, up to 696 adults with PHP will be given a self-management advice booklet and allocated by chance to one of four treatments: exercise, foot orthoses, combined exercises and foot orthoses, or no additional treatment. Participants will be sent a weekly text-message to collect pain scores for up to 12 weeks and then monthly from 3 to 12 months, as well as a questionnaire at 3, 6 and 12 months. Half-way through the trial, only treatments that appear to be reducing pain will continue to be offered and the trial will be stopped early if there is strong evidence that one treatment is better than the others, making the trial good value for money._x000D_ _x000D_ Patient and Public Involvement and Engagement: Patient representatives were involved in our pilot and feasibility trial and will support every stage of the main trial. Our lay co-applicant helped write this summary. Five patients with PHP took part in a workshop to help design the main trial. For example, they helped us decide how often pain should be measured. We will also involve patients to assist with our recruitment strategy and help us to interpret the trial findings, develop easily understandable messages to explain the findings and publicise the findings widely._x000D_ _x000D_ Dissemination: We will present and publish the findings at healthcare conferences, in medical journals, on relevant websites, through social media, and in general practices. Trial participants will be sent a summary of the results when the trial is completed. Articles about the trial will also be written for local magazines, newspapers, and radio.

Lay abstract: RESEARCH QUESTION: What is the clinical and cost-effectiveness of prefabricated foot orthoses and/or individualised exercises plus self-management advice (SMA) compared with SMA alone to treat adults with plantar heel pain (PHP) in primary care?_x000D_ BACKGROUND: PHP is the most common soft tissue foot complaint and impairs mobility, physical function, ability to work, and quality of life. Initial treatment is with analgesia and advice about rest, footwear, heel pads, weight loss and exercises. Referral to a podiatrist or physiotherapist is advised if symptoms are severe or persist. Although PHP is commonly said to resolve over 1-2 years, symptoms often become chronic. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of orthoses and exercises for PHP._x000D_ OBJECTIVES: To examine whether a SMA booklet plus prefabricated foot orthoses and/or individualised exercises leads to greater improvement in pain (primary outcome), first step pain, foot function, patient global rating of change, pain self-efficacy, illness perceptions, and ability to work than a SMA booklet alone in adults with PHP. We will assess recruitment, intervention fidelity, adherence and follow-up in a 6-month internal pilot and examine cost-effectiveness and treatment adherence and satisfaction._x000D_ METHODS:_x000D_ Design: multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot_x000D_ Setting: primary care. Treatment in NHS physiotherapy/podiatry services_x000D_ Duration: 51 months_x000D_ Target population: adults aged 18 years and over with PHP_x000D_ Participants will be randomised 1:1:1:1 to one of:_x000D_ • SMA booklet (control)_x000D_ • SMA booklet + pre-fabricated foot orthoses_x000D_ • SMA booklet + individualised exercises_x000D_ • SMA booklet + individualised exercises and pre-fabricated foot orthoses._x000D_ Outcomes will be collected by SMS text-message (weekly during weeks 1-12, monthly thereafter) and questionnaires at 12 weeks and 6 and 12 months. Primary outcome: change in PHP intensity (0-10 numeric rating scale (NRS)) between baseline and the average over weeks 6-12. _x000D_ Sample size: Up to maximum of 696 participants to detect an effect size 0.3 in average pain NRS over weeks 6-12 in at least one intervention arm against control (90% probability, 1-sided 5% significance, 20% loss to follow-up). The expected sample size ranges from 490-610. _x000D_ Adaptive design: an interim analysis will be performed when half of the target sample size, 348 participants, have completed the primary outcome, allowing futile interventions to be dropped or the trial stopped early (for efficacy or futility)._x000D_ TIMELINE: Months 0-9: set-up. 10-16: internal pilot. 10-33: recruitment. 10-36: intervention delivery. 10-45: follow-up. 25-26: interim analysis. 46-51: data cleaning, analysis, dissemination, final report._x000D_ ANTICIPATED IMPACT AND DISSEMINATION: New evidence will be provided for patients with PHP and their GPs, physiotherapists and podiatrists which will directly inform treatment decisions. We will make results freely available to patients, clinicians and commissioners, by publishing in peer-reviewed journals, on our website, through social media, and presenting at scientific meetings. Our PPIE group will help us translate findings into easily understandable messages and disseminate the results to the wider public. We will work closely with the NIHR Applied Research Collaborations, AHSNs, professional/specialist societies, royal colleges and charities to ensure wide dissemination and uptake.

Research activity codes: 6.3 MEDICAL DEVICES;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL