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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Fibromyalgia
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Fibromyalgia is a common type of arthritis which affects around 5-6% of the general population. It is characterised by debilitating widespread body pain. Fibromyalgia has traditionally been considered to be a disturbance in the way the brain processes pain and sensation. However, the type of pain experienced is increasingly recognised to overlap with nerve-related pain (neuropathic 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. Indeed, studies have shown that small nerve fibre damage occurs in ~50% of people with fibromyalgia.
In this study, we will determine the accuracy of changes in the nerves in the cornea (known as the corneal sub-basal nerve plexus) using a method called corneal confocal microscopy to identify small nerve fibre damage in fibromyalgia syndrome (referred to as fibromyalgia in the lay application) 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 a method called microneurography and characteristics (phenotype) of pain.
Corneal confocal microscopy is an eye test which allows direct visualisation of the small nerve fibres in the cornea in an area called the corneal sub-basal. These are the same type of nerves involved in nerve-related pain (neuropathic pain) and are present in skin. This technique is non−invasive, real−time, rapid (taking about 10 minutes) and readily repeatable. In a range of disorders, such as diabetes, corneal confocal microscopy is as accurate as skin biopsy in detecting and stratifying the severity (classifying the amount) of small nerve fibre damage.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. People will be excluded if they have a positive history of diabetes, high risk susceptibility to complications of COVID-19 as defined by current UK government guidelines, malignancy, connective tissue, autoimmune diseases, poorly controlled hypothyroidism, Addison’s disease, vitiligo, current systemic, infectious disease, autoimmune disorder, chronic renal failure, liver failure, any other rheumatological disease i.e. rheumatoid arthritis, Sjorgren’s syndrome, etc, history of peripheral neuropathy, current or previous history of alcohol abuse, current psychosis or psychiatric disorder which does not allow for the completion of the scientific protocol*2. Any contraindication to skin biopsy i.e history of blood dyscrasias, coagulopathy, use of warfarin or a novel anti-coagulant agent (dual anti-platelet therapy is permitted for skin biopsy), previous non-healing limb ulcers, active infection at biopsy sites, recurrent cellulitis, active dermatological disorder at the biopsy site, peripheral vascular disease3. Any contraindication to microneurography i.e. use of warfarin or a novel anti-coagulant agent, permanent pacemaker, any implanted electronic device (in the microneurography group only)4. Any contraindication to nerve conduction studies i.e. use of warfarin or a novel anti-coagulant agent, permanent pacemaker, any implanted electronic device. If there is a contraindication to nerve conduction studies then participants can continue with the rest of the protocol (VPT is <15 volts and NDS is <4 will be defined as no definitive large fibre involvement)5. Abnormal nerve conduction studies (using age-matched normative cut-offs) or VPT (>15 volts) signifying large fibre neuropathy6. Systemic or localised neurological conditions causing pathology of corneal nerves i.e. cluster headaches, trigeminal neuralgia, previous severe traumatic head injury7. Concurrent ocular disease, infection or inflammation8. People with moderate-severe dry eye based on the Schirmer’s test (<8 mm wetting of the paper after 5 minutes)9. Any corneal pathology due to hereditary, trauma or infection (including current infection)10. Unable to complete the experimental protocol at initial assessment11. Inability to undertake corneal confocal microscopy or skin biopsy for any reason12. Participating in any other interventional (CTIMP) research trial13. Inability to safely walk to the research centres14. Inability to provide informed consent
*Solid organ transplant recipients, people with severe respiratory conditions including all cystic fibrosis, severe asthma and severe chronic obstructive pulmonary (COPD), people with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as Severe combined immunodeficiency (SCID), homozygous sickle cell), people on immunosuppression therapies sufficient to significantly increase risk of infection and women who are pregnant with significant heart disease, congenital or acquired.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Uazman
Alam
+44 (0)151 529 5918
uazman.alam@liverpool.ac.uk
The study is sponsored by University of Liverpool and funded by Versus Arthritis.
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