Title: Tendinopathy: Treatment effects and mechanisms (Tendinopathy TEAM).
Funder: Health Education England

Abstract: Background Tendinopathy is common, recurrent, painful and limits the activity of those affected. It causes substantial direct NHS costs and substantial indirect costs due to reduced physical activity participation. There are consequential effects on occupation and exercise for health. Taken collectively, tendinopathies are the second most common problem seen by physiotherapists in the NHS. Tendinopathies are typically slow to respond to conservative treatment, usually consisting of progressive eccentric loading (EL). No established interventions have high success rates. We do not know why some people improve and others do not. Surgery often has unsatisfactory outcomes, many side effects and long recovery periods. Recent advances have suggested that two intermediate interventions - shock wave therapy (SWT) and high volume image guided injection (HVIGI) - have the potential to improve outcomes for people with tendinopathy. SWT typically involves three treatments, one week apart, and is increasingly accepted into mainstream practise with stage ll clinical trials demonstrating efficacy. HVIGI has only been subject to evaluation by case series with some encouraging findings of statistically significant and clinically meaningful improvements on well-validated outcome measures. For this project I will focus on the paradigmatic case of Achilles Tendinopathy (AT). This will set the scene for project grant applications to specifically investigate rotator cuff tendinopathy in a similar manner, and clinical trials of complex rehabilitation interventions. Further, we will aim to secure parallel monies to explore treatment mechanisms. Aims My overarching aim is to test the effectiveness and cost effectiveness of SWT and HVIGI when added to EL. Specific objectives are: To pilot the interventions and study procedures To run a three arm RCT for effectiveness To monitor adverse events To conduct a cost-effectiveness analysis To do a process evaluation of the trial and the interventions Plan of investigationThe primary aim will be realised by a two-centre, three-armed randomised clinical trial of EL (usual treatment) compared to EL plus SWT and HVIGI plus EL. The primary outcome measure will be the Victorian Institute of Sport Assessment Achilles (VISA-A), a well validated and reliable measure of function and recent pain at twelve months. Secondary measures will include: recent pain (VAS score); treatment satisfaction (Likert scale); adherence (exercise diaries); adverse events (overtly solicited self report); global perceived change (Likert scale); self-reported exercise levels (modified IPAQ); health-related quality of life (EQ-5D); calf function (using a clinical graded loading challenge). Further, we will collect data on costs and interview participants and care delivery staff concerning trial delivery. All measures will be applied at baseline and 6 weeks, then 3, 6, 12 and 24 months post-randomisation. To identify a clinically meaningful difference between groups of 15 on the VISA-A at a power of 90% and a significance level of 2.5% (Bonferroni correction for multiple comparisons) at the twelve month post treatment follow-up we will recruit 180 participants. Subsequent follow-ups at one and two years will assess long-term treatment effects. Potential benefits to patients and the NHS Patients in the NHS will rapidly be able to benefit from the trial results, should they favour a particular intervention combination. The trial resources will include patient and staff resources designed to facilitate management such as leaflets and protocols, published freely on a website in addition to usual dissemination routes. SWT and HVIGI should be readily available, as they are increasingly used and easily learned. Parallel work on mechanisms may help inform future work on personalised care. Finally, the reports on costs and process of care delivery will facilitate adoption into usual care.

Lay abstract: Tendinopathy is a common, painful, recurrent condition that affects both active and sedentary individuals. We aim to discover how we can best treat Achilles tendinopathy conservatively. We will run a clinical trial to test the effectiveness of two promising novel treatment when added to best usual care. Further, we will evaluate the process of care delivery and measure costs. This new knowledge should help us treat existing problems better and learn how to generalise these findings across the NHS. In related studies we will address why treatments work only for some people and extend our focus to other tendinopathies.

Research activity codes: 6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS