Fibromyalgia Musculoskeletal Diseases Fibromyalgia
Conditions
Interventions
Participants with fibromyalgia will be requested to provide details of their medical history, current and past use of pain medication and a record of their height, weight and blood pressure will be co
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Fibromyalgia patients (diagnosis of FMS defined by one of the current guidelines criteria) 3. Healthy volunteers (no history of FMS, diabetes, metabolic, neurological disorders or small fibre neuropathy or conditions which may cause small fibre neuropathy)
Exclusion criteria
Exclusion criteria: 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 disease 3. 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) signifying large fibre neuropathy 6. Systemic or localised neurological conditions causing pathology of corneal nerves i.e. cluster headaches, trigeminal neuralgia, previous severe traumatic head injury 7. Concurrent ocular disease, infection or inflammation 8. 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 assessment 11. Inability to undertake corneal confocal microscopy or skin biopsy for any reason 12. Participating in any other interventional (CTIMP) research trial 13. Inability to safely walk to the research centres 14. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal nerve fibre pathology measured using corneal nerve fibre density (CNFD) at baseline and additionally at 12 months in a sub-group of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Corneal nerve fibre pathology measured using corneal nerve fibre length (CNFL) and corneal nerve branch density (CNBD) at baseline and additionally at 12 months in a sub-group of participants. 2. Intraepidermal nerve fibre density (IENFD) determined using skin biopsy at baseline and small fibre dysfunction determined by microneurography (assessed once during an 18-month window post visit 1). 3. Small and large nerve fibre function determined using thermal, mechanical, vibration and pressure detection and pain thresholds (quantitative sensory testing protocol) at baseline and additionally at 12 months in a sub-group of participants. | — |
Countries
United Kingdom
Outcome results
None listed