NI-FMS V1
Research type
Research Study
Full title
Neuroimmune interactions during fibromyalgia syndrome flare episodes
IRAS ID
352716
Contact name
Nicholas Fallon
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Fibromyalgia syndrome (FMS) is a chronic pain condition affecting 3–7% of the global population. Its causes remain unknown, leading to limited treatment options and persistent daily pain for many patients. A common feature of FMS is "flare" episodes—periods of heightened pain and symptom intensity—sometimes occurring without an identifiable trigger. This research aims to investigate flares without a clear cause, potentially shedding light on the underlying causes of FMS.
Research suggests that people with FMS process pain differently, resulting in symptoms like allodynia (pain from non-painful stimuli) and hyperalgesia (intensified pain response). The brain, and central nervous system, similarly show differences in brain activity in response to pain in FMS patients. Separately, prior studies have identified immune substances (autoantibodies) and cells in FMS patient’s blood and skin that may contribute to FMS symptoms. Very recent research has indicated that the gut microbiome in FMS has a specific, abnormal signature, and may contribute to cause changes in the function of patients’ immune cells.
This study will explore possible connections between immune substances, microbiome, and brain structure and activity, particularly during flare episodes.
Participants will complete questionnaires to assess symptoms, medical history interviews, and sensory testing to evaluate skin sensitivity to pressure and temperature. They will also provide blood samples and undergo skin biopsies. Magnetic resonance imaging (MRI) of the brain will be conducted at baseline (before a flare), during a flare, and after the flare subsides. Additional sensory testing and a final blood sample will follow during the post-flare visit.
These assessments will allow us to characterise participants at baseline and identify any changes which occur during a flare episode. We anticipate that these assessments will provide insight into why these flares happen, and their relevance to symptoms seen in fibromyalgia syndrome.REC name
Wales REC 6
REC reference
25/WA/0095
Date of REC Opinion
24 Mar 2025
REC opinion
Favourable Opinion