Impact of neuropathic pain treatment on MRI correlates of PDPN
Research type
Research Study
Full title
The impact of optimised neuropathic pain treatment on the magnetic resonance imaging correlates of painful diabetic peripheral neuropathy
IRAS ID
258512
Contact name
Solomon Tesfaye
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Diabetic painful peripheral sensorimotor neuropathy is an increasingly common chronic complication of diabetes mellitus. The condition affects 25% of people with diabetes mellitus and leads to severe pain in the feet. The condition leads to massively increased healthcare expenditure and impacts upon patients’ quality of life, mental and physical health and work productivity. Unfortunately, our treatments for this condition are inadequate as a result of our poor understanding of the pathophysiological mechanisms which lead to neuropathic pain. Magnetic resonance imaging (MRI) studies have identified a variety of changes within the central nervous system in people with DSPN and painful-DSPN, thus suggesting there may be pathophysiological alterations within the brain which may contribute to the generation and maintenance of neuropathic pain in DSPN.
This sub-study of OPTION-DM (Optimal Pathway for TreatIng neuropathic paiN in Diabetes Mellitus trial (REC reference 16/YH/0459) aims to explore the presence of cerebral structural, neurochemical, blood flow and functional changes on various MRI modalities and their relationship to the control of neuropathic pain on, and after withdrawal, of painful-DSPN medication treatments.
The primary aim of the study is to determine whether there are central nervous system changes using advanced MRI in people with painful diabetic peripheral neuropathy (painful-DSPN) when optimally treated for their painful symptoms compared to without treatment.
20 patients enrolled in OPTION-DM will be recruited for this study. If eligible we will obtain clinical data from the patient and the OPTION-DM report forms and they will have two MRI scans , one at the final visit of their last treatment pathway when their neuropathic pain is optimally controlled and again one week after withdrawal of their treatment.
MR imaging and spectroscopic data will be used to assess brain structure, function and neurochemistry. Data will be collected pre- and post-treatment withdrawal and following analysis, measures will be compared.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0007
Date of REC Opinion
28 Jan 2019
REC opinion
Favourable Opinion