AAB in FMS V1.0
Research type
Research Study
Full title
Serum immunoglobulin G autoantibodies in patients with fibromyalgia
IRAS ID
240099
Contact name
Andreas Goebel
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
The causes of fibromyalgia syndrome (FMS), a common widespread pain condition, are incompletely understood. Therefore no specific drug treatment exists, and many patients will not obtain effective pain relief from available, unspecific pain treatments.
Recent research has indicated that patients' sera contain proteins termed 'autoantibodies', which can painfully sensitise nerves and may thus be responsible for the patients’ pain. This study is conducted to obtain serum from a larger group of patients, and to assess such autoantibodies and other serum substances related to FMS in detail using animal and cellular studies described in detail later in this application.Patients will be identified from the Walton Centre NHS Foundation Trust (WC); WC will serve as a ‘patient identification centre’, and all study procedures will be conducted at University of Liverpool premises (at ‘Pain Research Institute’, PRI), situated 50m from WC. Identified patients will be approached either by letter or during WC clinic appointments, and provided with the study patient information leaflet. Interested patients will be invited to attend a single appointment at PRI.
Adult patients are eligible if they have moderate or severe pain fulfilling American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, and have a FMS duration of >=1 year. Pregnant or breastfeeding patients will be excluded.
At their appointment, following consent suitable patients (n=100) will be assessed with questionnaires, examined for their musculoskeletal sensitivity, and will donate 50ml of blood (4.5 table spoons). 30 healthy volunteers will also donate blood. Travel expenses will be reimbursed for all participants.
5 patients with sensitising auto-antibodies detected in initial experiments will be invited back for a second visit, to donate 24 tablespoons blood following safety screen.
Remaining serum will be stored frozen for 30 years.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0262
Date of REC Opinion
17 May 2018
REC opinion
Unfavourable Opinion