OPTION-DM trial

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

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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 in follow up.


Participant information

Site contact details

England

Participating site

Main contact

Aintree University Hospitals Dr Uazman Alam
Tel: +44 151 529 5920

Sharron Birch
Tel: +44 151 529 5935

Barbara Martin
Tel: +44 151 529 5939
Countess of Chester Hospital Susan Seal
Tel: +44 124 436 3619
Chorley and South Ribble Hospital Chandbi Sange
Tel: +44 125 724 7016 or +44 741 523 0883
Email: chandbi.sange@lthtr.nhs.uk
Gateshead Health NHS Foundation Trust Wendy Stoker
Tel: +44 191 445 3224                                             
Harrogate District Hospital Laura Dinning, Christine Cassidy or Taryn Ward
Tel: +44 142 355 3267
Email: hdft.diabetesresearch@nhs.net
Ipswich Hospital Jo Rosier or the Diabetes Research Team
Tel: +44 147 370 4759
Email: Research.AdultDiab@ipswichhospital.nhs.uk
King's College Hospital NHS Foundation Trust Louisa Green / Olabisi Awogbemila
Tel No. 020 3299 1851 /1852
Email: louisa.green@nhs.net /olabisi.awogbemila@nhs.net
Nottingham University Hospitals Diabetes Research Team
Tel: +44 115 969 1169 
Royal Wolverhampton NHS Trust  
Sheffield Teaching Hospitals Green Team
Tel: +44 114 271 3339
Tameside Hospital

Dr Ed Jude
Tel: +44 161 922 6445
Email: Edward.jude@tgh.nhs.uk

Heather Savill
Tel: +44 161 922 4078
Email: heather.savill@tgh.nhs.uk

Scotland

Participating site Main contact
University Hospital Monklands - NHS Lanarkshire Linda Macliver or Dina Bell
Tel: +44 123 671 2472

University Hospital Hairmyres - NHS Lanarkshire

Linda Macliver or Dina Bell
Tel: +44 135 558 5230

Study medication film

Sensory exam film

Service Evaluation: Prescribing Practices for DPNP

Diabetic peripheral neuropathic pain (DPNP) affects up to a quarter of patients with diabetes. The mainstay of treatment for DPNP is pharmacotherapy however, current NICE guidance is not based on robust evidence.

OPTION-DM is a phase III clinical trial, funded by the NIHR HTA programme, which aims to identify the most clinically beneficial treatment pathway for DPNP. In order to assess the impact of research it is important to understand current practice, however, we do not have a clear picture of prescribing practices for DPNP in the UK. With this in mind, we are conducting a service evaluation to better understand the current prescribing practices in primary care. This will involve a short (5 minute) survey to be completed by GPs about their current practice. This information will provide a baseline against which we can compare future surveys.

For more information on how we use the data, please refer to the Privacy Notice.

Downloads

Protocol paper (PDF, 1MB)

OPTION - DM privacy notice (PDF, 229KB)


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

+44 114 222 0743

David White Research Associate CTRU, University of Sheffield

d.a.white@sheffield.ac.uk

+ 44 114 222 0807

Jennifer Petrie Trial Manager CTRU, University of Sheffield

j.petrie@sheffield.ac.uk

+44 114 222 0676

Katie Sutherland Research Assistant CTRU, University of Sheffield

k.sutherland@sheffield.ac.uk

+44 114 222 4023

Zoe Furniss Trial Support Officer CTRU, University of Sheffield

z.furniss@sheffield.ac.uk

+44 114 215 9122

Steven Julious Statistician Medical Statistics Group, University of Sheffield

s.a.julious@sheffield.ac.uk

+44 114 222 0709

Mike Bradburn Statistician CTRU, University of Sheffield

m.bradburn@sheffield.ac.uk

+44 114 222 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

England

Site Investigator
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
Aintree University Hospital Dr Uazman Alam
Nottingham University Hospitals NHS Trust Dr Ravikanth Gouni
Harrogate and District NHS Foundation Trust Dr Deirdre Maguire
Countress of Chester Hospital NHS Foundation Trust Dr Haris Ahmed
Gateshead Health NHS Foundation Trust Dr Vasileios Tsatlidis
King's College Hospital NHS Foundation Trust Dr Prashanth Vas
Royal Wolverhampton NHS Trust Dr Christian Hariman

Scotland

Participating site Main contact
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.

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