BRU research round up: Theme 6 – Evaluation of new therapies and devices

Theme Six in the BRU is led by Professor David Felson, with support from a multidisciplinary research group (Research in OsteoArthritis Manchester (ROAM)) of clinical and non-clinical scientists, including Professor Terry O’Neill (Rheumatology), Mike Callaghan (Physiotherapy),  Richard Hodgson (Imaging), Richard Jones (Biomechanics) and Tim Cootes (Computer Vision).

The broad theme aim is to explore and evaluate new therapies and devices for the treatment of Osteoarthritis. Osteoarthritis is the leading cause of pain and disability in the UK with up to one in eight men and women over the age of 65 years having evidence of symptomatic knee OA. To date, however, there are no effective therapies which reduce symptoms and progression of the disease; in part because of the absence of a good experimental model for the disease.

The ROAM research team is aiming to develop a new human experimental model of OA treatment by looking in detail at the whole joint structure using MRI imaging, including bone and the joint lining, and finding out how these structures change following a series of interventions.  In this way it is hoped that it will be possible to more rapidly develop and test new treatments and therapies for osteoarthritis.

The Research group is undertaking a program of evaluation of new medical devices and therapy for the treatment of knee osteoarthritis. Below is an update on the research currently underway and in development in the ROAM group.

Study update

The main focus of the group at this time is the ‘IN RESPOND’ study.  This is a randomised trial of wedge insoles vs. a placebo, a neutral show insole, which aims to determine, in patients with symptomatic knee OA, whether therapy is linked with a reduction in knee pain as well as favourable biomechanical change within the knee. Since studies have shown that wedge insoles, despite favourably lowering the load across the medial knee, do not reduce knee pain, we have adopted a new approach, using the gait laboratory to identify persons with strong reductions in medial load and randomising them to wedge or neutral.

The study has recently started screening patients and is using the 3T MRI scanner in the NIHR / Wellcome Trust Manchester Clinical Research Facility (MCRF) which was purchased with the help of strategic investment from the BRU. By utilising this scanner, we are able get the best rate for our scans, helping to keep costs down.

In addition Richard Hodgson is developing, enhancing and fine tuning MRI acquisition protocols to improve image quality without the use of contrast agents. This work will help reduce the time required on the scanner and enhance the quality of data which is obtained.

Other proposed studies which are in the development phase include a randomised controlled trial looking at the effect of a bone active drug on reducing pain and structural change in knee OA and also a trial looking at an external rotation hip brace with a view to reducing pain arising from OA in the patellofemoral joint.  ROAM has established one of the first collaborations outside of oncology with the MAHSC Clinical Trials Unit, who are assisting in the development and running of the new studies.

Staff updates

Nasimah Maricar, senior physiotherapist is completing a 5 year part time NIHR clinical fellowship and hopes to submit her PhD in the next few months. Nasimah is planning to apply for a postgraduate fellowship in the coming year focused on improving outcome assessment in trials of knee OA.

Dr Vikram Swaminathan, surgical trainee is completing the first year of a BRU funded MPhil which he is planning, with support from MAHSC (as part of their expanding research platform for orthopaedics), to continue for a further year and convert  his MPhil to MD.  His research will focus on outcome following knee replacement therapy

Justine Theaker, physiotherapist will be starting a BRU funded MPhil in the autumn looking at the effectiveness of physical therapy treatment outcomes in post-operative hip osteoarthritis.

ROAM has been working with Janet Suckley, a consultant physiotherapist, to help develop a research referral pathway to enhance recruitment from GP practices, including developing an effective system of research alerts on GP IT systems.