Title: A feasibility and pilot trial of the effectiveness of exercise therapy and orthotics in the treatment of plantar heel pain. (TReatments of Exercise AnD Orthotics for plaNtar heel pain: The TREADON pilot feasibility trial)
Funder: Department of Health and Social Care

Abstract: Plantar heel pain (PHP) is a common and debilitating foot complaint with a significant and negative impact on function, health and quality of life. General practice management pathways recommend treatment with pain medication and advice regarding rest, heel pads and weight-loss. Onward referral to a podiatrist or physiotherapist is suggested only when symptoms persist beyond three months. Although PHP is commonly thought to be a self-limiting and benign condition that typically resolves over one to two years, recent data show that no more than 20% of patients report improvement over 18 months. Despite this only 40% of patients with PHP access physiotherapists and podiatrists for help. Physiotherapists and podiatrists offer foot orthoses and exercise as treatment options. Research to date suggests these treatments might be effective for heel pain but there is insufficiently robust evidence to support clinical decisions and cost effectiveness. This may help explain why GPs restrict onward referral to physiotherapists and podiatrists. We plan to conduct a feasibility and pilot trial which will inform a future main trial to test these interventions. The aims of the feasibility trial are to; i) compare the success of three different recruitment methods, ii) to determine which interventions to test in the future main trial by collecting data regarding; adherence (which is key to intervention effectiveness), satisfaction with and credibility of each intervention iii) compare feasibility of follow up between two outcome measures that patients feel best reflect their goals of treatment iv) inform the sample size calculation and analysis for the main trial. We plan to recruit 80 participants from up to 12 general practices over a 9-months to a pragmatic parallel-group feasibility and pilot trial with participants randomised to one of 4 interventions: - high-quality self-management advice booklet (SMA), as a control arm - SMA plus individualised exercise programme progressed in up to 6 clinical sessions with either a podiatrist or physiotherapist over 12 weeks - SMA plus prefabricated foot orthoses used for or a minimum of 4 hours a day, monitored in up to 6 clinical sessions with either a podiatrist or physiotherapist over 12 weeks - SMA plus a combination of exercise and foot orthoses described in (ii) and (iii) above. Follow-up data will be collected in two ways; firstly via a numerical pain rating scale (NRS 0-10) collected by weekly text message for 12 weeks which will allow the time to patients report of being significantly better to be derived, secondly via the Foot Function Index Pain subscale self-report questionnaire at 12 weeks from the point of randomisation. PHP is associated with reduced quality of life and potentially poor long-term health. Currently there is insufficient evidence to inform clinical decisions about effective treatments and patients report feeling that they are left to get better on their own. Interventions such as foot orthoses and exercise may provide faster symptom resolution, better reduction in pain, and better outcomes overall compared with current first line primary care. High-quality evidence, in a primary care population is needed in order to help inform patients, clinicians and commissioners whether these treatments should be offered routinely. This is particularly true for orthotic devices which have generally received a very low priority in NHS research, despite the considerable cost of services and lack of evidenced treatments. This feasibility and pilot trial will provide important information on which to optimise the plans for a future large definitive RCT in the NHS which will test the clinical and cost-effectiveness of individualised exercise and foot orthoses for adults with PHP and will inform NHS policy and commissioning decisions for treatment costs and options of these interventions.

Lay abstract: Pain under the heel (plantar heel pain) is relatively common condition with 1 in 10 adults affected during their lifetime. Plantar heel pain restricts the ability to walk, complete everyday tasks and work. GPs generally give pain medication and advice yet the problem often continues and lasts more than 18-months. Evidence suggests treatments of shoe insoles (foot orthoses) and personalised exercise may reduce pain and improve function for patients but there is a lack of high quality research to confirm this. We plan a small (pilot) trial to test certain procedures and provide information for a future main trial. The main trial will investigate costs and the effects on pain and function of personalised exercise programmes and /or shoe insoles for adults with plantar heel pain. Before the main trial we need to: Compare the success of three methods of recruiting patients Establish how patients follow the different treatment prescriptions (this is important to the likely response to treatment), and ask them which they find convincing/satisfactory. Test the practicality of collecting two different measures of patients response to treatments. Collect information to help us decide how many patients are needed for the future trial. We will recruit 80 participants, over 9 months, from 12 general practices. Participants will be allocated by chance to one of four treatments: High quality self-management advice. Self-management advice and shoe insoles. Self-management advice and exercise. Self-management advice and a combination of exercise and shoe insoles. Participants allocated to exercise or foot insoles will receive up to 6 treatment sessions over 12-weeks deepening on their progress. Each week we will send a text message (or email/telephone call) to collect pain scores. At 12-weeks we will ask patients to complete a postal questionnaire. Findings will be discussed with patients representatives and used to design the main trial.

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