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OPTION-DM: Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus trial

The OPTION-DM trial is exploring three different treatment pathways using amitriptyline, duloxetine and pregabalin, and their combinations, in the treatment of painful diabetic neuropathy.

Background

The number of people with diabetes is growing rapidly in the UK and is predicted to increase by a further 1.8 million by 2025. Unfortunately, diabetes causes nerve damage that causes severe painful symptoms in the feet, legs and hands. This is known as painful diabetic neuropathy and one quarter of people with diabetes experience these symptoms. As this pain is felt every day, and can be disruptive to carrying out simple daily activities, this often results in a poor quality of life, and depression. Unfortunately current individual medications provide only partial benefit in around half of all patients, with many enduring inadequate pain relief and unwanted reactions. Not surprisingly therefore, many patients are frustrated with not being able to work and too many visits to see the doctor. The negative impact on them, their families and the NHS is considerable.
The National Institute for Health and Care Excellence (NICE) recommends a choice of four drugs; amitriptyline, duloxetine, pregabalin or gabapentin, as initial treatment for painful diabetic neuropathy. If the initial treatment is not fully effective, NICE recommends adding one of the other drugs in combination with the first drug. However, neither these individual drugs or the different combinations have been compared against each other to see which is the most effective.

The OPTION-DM trial

In this study, we aim to find out the most effective initial treatment, and then the best additional treatment for patients with painful diabetic neuropathy. This will improve patient care and quality of life, as well as benefitting doctors who treat patients with painful diabetic neuropathy, and the NHS, as improved pain management reduces patient visits to both GPs and hospitals.
We aim to recruit 392 patients from 8 hospital clinics and 80 GP practices. Patients will be allocated to one of the three treatment pathways starting with either amitriptyline, duloxetine or pregabalin for 6 weeks, and for people still in pain, another drug added for a further 10 weeks. Each patient will go through all three treatment pathways in turn, and randomisation will dictate the order that each patient will receive each pathway. The total length of the study for each patient will be one year. During this period, patients will be contacted by telephone and seen in hospital regularly. Study medications will be started at a low dose and increased gradually to the right dose for the patient. Throughout the study, response to treatment will be measured using pain diaries which patients will be asked to complete. We will also use measures of quality of life, mood, sleep and reactions to the drug, using patient completed questionnaires. The cost effectiveness of each treatment pathway will also be measured.

Study Update

The trial is currently recruiting.

Project Team

Name Role Organisation Contact
Professor Solomon Tesfaye Chief Investigator Sheffield Teaching Hospitals solomon.tesfaye@sth.nhs.uk
Dr Dinesh Selvarajah Co-Investigator Sheffield Teaching Hospitals/University of Sheffield d.selvarajah@sheffield.ac.uk
Professor Cindy Cooper Director, CTRU CTRU, University of Sheffield

c.l.cooper@sheffield.ac.uk

0114 222 0743

David White Research Associate CTRU, University of Sheffield

d.a.white@sheffield.ac.uk

0114 222 0807

Jennifer Petrie Trial Manager CTRU, University of Sheffield

j.petrie@sheffield.ac.uk

0114 222 0676

Katie Sutherland Research Assistant CTRU, University of Sheffield

k.sutherland@sheffield.ac.uk

0114 222 4023

Jessica Welburn Trial Support Officer CTRU, University of Sheffield

j.welburn@sheffield.ac.uk

0114 22 25444

Steven Julious Statistician Medical Statistics Group, University of Sheffield

s.a.julious@sheffield.ac.uk

0114 222 0709

Mike Bradburn
Statistician CTRU, University of Sheffield

m.bradburn@sheffield.ac.uk

0114 222 0706

Amanda Loban

Simon Waterhouse

Emily Turton

Data Management Team CTRU, University of Sheffield

a.loban@sheffield.ac.uk

s.waterhouse@sheffield.ac.uk

e.j.turton@sheffield.ac.uk

Participating Sites

Site Principal Investigator

                                                                    England

Sheffield Teaching Hospitals NHS Foundation Trust Professor Solomon Tesfaye
Ipswich Hospital NHS Trust Dr Gerry Rayman
Tameside Hospital NHS Foundation Trust Dr Edward Jude
Lancashire Teaching Hospitals NHS Foundation Trust Professor Satyan Rajbhandari
Lancashire Care NHS Foundation Trust Professor Satyan Rajbhandari
Aintree University Hospital Dr Uazman Alam
Nottingham University Hospitals NHS Trust Dr Ravikanth Gouni
University of Oxford Professor David Bennett
Harrogate and District NHS Foundation Trust Dr Deirdre Maguire
Countress of Chester Hospital NHS Foundation Trust Dr Haris Ahmed
Royal Liverpool and Broadgreen University Hospitals Trust Dr Pallavi Hedge

                                                             Scotland

Ninewells Hospital - NHS Tayside Professor Rory McCrimmon
University Hospital Monklands - NHS Lanarkshire Dr Marion Devers
University Hospital Hairmyres - NHS Lanarkshire Dr Claire McDougall

This project is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 15/35/03). Any views or opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

Sponsor

Sheffield Teaching Hospitals