DEFINE-FMS
Research type
Research Study
Full title
Diagnosing and dEtermining the contribution of small FIbre NEuropathy to pain in FibroMyalgia Syndrome
IRAS ID
234270
Contact name
Uazman Alam
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN13134437
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In this study, we will determine the to identify small nerve fibre damage in fibromyalgia syndrome compared to the current reference standard, skin biopsy. We will then explore the relationship between small nerve fibre damage (small fibre neuropathy), its function through determining the characteristics (phenotype) of pain.
Fibromyalgia is a common type of arthritis which affects around 5-6% of the general population. It is characterised by debilitating widespread body pain. There has been a recent interest in the role of small nerve fibres (which are the pain transmission nerves) and their role in fibromyalgia.
To find out whether patients have damage to the structure of the small nerve fibres the technique of skin biopsy is used in specialist centres. However, this is an invasive procedure and laboratories for skin biopsy testing in the UK are severely limited. We predict that equally accurate information can be gained from quantification of the subbasal nerve plexus of the cornea with corneal confocal microscopy (an eye test which allows direct visualisation of the small nerve fibres). These are the same type of nerves involved in nerve-related pain (neuropathic pain). This technique is non−invasive, real−time, rapid and readily repeatable. We also intend to study the function of small nerve fibres in a smaller number of participants through microneurography.
To carry out this project, 50 healthy-volunteers and 77 people with fibromyalgia will have detailed assessment of pain and a comprehensive evaluation of small nerve fibres by corneal confocal microscopy and skin biopsy. In addition, microneurography will be undertaken in 14 healthy-volunteers, 14 people with fibromyalgia and no small nerve fibre damage and 14 people with fibromyalgia with small nerve fibre damage. Twenty-eight people with fibromyalgia will be followed up at 1 year with corneal confocal microscopy and skin biopsy (primarily from those undertaking microneurography).REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0138
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion