£3m grant awarded to Sheffield to lead vital study into treatment of diabetes-related chronic pain
A world-leading diabetes team at Sheffield Teaching Hospitals has been awarded a £3m grant to conduct a study into the effectiveness of pain control drugs in patients with chronic pain caused by diabetes.
The study will compare the effectiveness of the three main drugs used to treat patients who suffer from painful diabetic neuropathy, and is funded by the National Institute for Health Research Health Technology Assessment (HTA) Programme.
The study, in collaboration with the University of Sheffield Clinical Trials Research Unit (CTRU), aims to establish which drug or combination of drugs is best for patients with the condition. At the moment there is considerable uncertainty regarding the best treatment pathway for sufferers, and the trial will help to determine the best treatment option for patients and could potentially save millions of pounds on drug costs.
The grant is one of the biggest awards ever given to a Sheffield Teaching Hospitals research team.
The study will last for 3 ½ years and will include around 400 patients at eight UK centres, led by Sheffield.
Professor Solomon Tesfaye, a Consultant Physician/Endocrinologist at the Royal Hallamshire Hospital, Sheffield, and Honorary Professor of Diabetic Medicine at the University of Sheffield, is leading the research.
He said: “Sheffield is a world leader in the treatment of painful diabetic neuropathy, and the size of the grant reflects the importance of this study. We need to know both what is the best treatment for patients and the most cost effective.
“This research will help us to find out which patients and what kind of pain responds best to which drugs. Apart from improved pain management resulting in better quality of life for patients, it might also save the NHS a considerable amount of money in drug costs.
“This trial has a potential benefit to sufferers, carers, health care professionals and the NHS.”
Painful diabetic neuropathy affects about 25% of diabetes patients. In sufferers, nerve damage caused by diabetes leads to chronic and sometimes unbearable pain, from persistent aching to burning or stabbing sensations. This in turn can affect mood, sleep and quality of life and lead to associated mental health problems such as depression and anxiety, which exacerbate the condition and create a vicious cycle.
At the moment there is an element of ‘trial and error’ in finding the best drugs for particular patients. Knowing in advance which combination of drugs is likely to work best would lead to patients receiving the most effective pain-relief more quickly and prevent unnecessary spending on expensive drugs which may not turn out to be the most effective treatment option.
Patients taking part in the study will undergo three different treatment pathways, and keep a daily pain diary rating their pain intensity. The study will also track mood, sleep, quality of life and functionality of patients on the different drug combinations, with the aim of establishing the most clinically effective treatment pathway as well as measuring cost effectiveness.
Anybody interested in taking part in the study can contact Sheffield Teaching Hospitals on 0114 271 2204. For more information visit www.sheffield.ac.uk/scharr/sections/dts/ctru/option-dm
Case study
Patient Tracey Smythe, 47, of Parson Cross, Sheffield, was diagnosed with painful diabetic neuropathy in 2009.
The trial could offer sufferers such as her a more effective combination of drugs to improve pain control that may translate in better functioning, sleep and quality of life.
She said: “When I was diagnosed a lot of people did not know what it was or have much of an understanding of it, but it has a big impact on your life.
“Before this I socialised a lot and went out with friends, but I don’t do any of that now. Because the pain is worst at night, it leaves you totally exhausted. I haven’t had a decent night’s sleep in seven years – I wake up three or four times a night with the pain. Without a decent night’s sleep, I can’t function and my mood fluctuates.
“I can’t walk very far before the pain starts kicking in. I stumble a lot and have fallen twice, and I have it in my hands and arms as well so I drop things. I can’t take the dogs for a walk.
“There is a consistent background pain, but on top of that you get burning pains and pins and needles and shooting pains. Some things trigger the pain, but other times it can come on when you are just sitting down.”
The illness has caused her to give up her job as a community carer, and she relies on her husband and two daughters to help her day-to-day.
She said: “Medication makes a difference, but not a big difference all of the time. Over the years I have tried quite a lot of different medication and some of it helps, some doesn’t, and some your body gets used to over time.
“I have tried other things as well, like mindfulness, to try and cope with the pain. If this trial can help to find a more effective way of managing the pain then it will make a massive difference to me.
“I would love to get a good night’s sleep, get my independence back, be less reliant on my husband and daughters and not feel like a prisoner in my own home. I want to feel normal.”
ENDS
MEDIA CONTACT:
John Birch, Communications Officer
Tel: 0114 226 8989
Email: john.birch@sth.nhs.uk
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