OPTION-DM trial
Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus trial (OPTION-DM)
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 now complete.
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 |
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
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 |
+44 114 222 0743 |
| David White | Research Associate | CTRU, University of Sheffield |
+ 44 114 222 0807 |
| Jennifer Petrie | Trial Manager | CTRU, University of Sheffield |
+44 114 222 0676 |
| Katie Sutherland | Research Assistant | CTRU, University of Sheffield |
+44 114 222 4023 |
| Zoe Furniss | Trial Support Officer | CTRU, University of Sheffield |
+44 114 215 9122 |
| Steven Julious | Statistician | Medical Statistics Group, University of Sheffield |
+44 114 222 0709 |
| Mike Bradburn | Statistician | CTRU, University of Sheffield |
+44 114 222 0706 |
| Data Management Team | CTRU, University of Sheffield |
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 |
Sponsor
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.
Sheffield Teaching Hospitals
Publications
The Lancet: Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial