Specialty: Musculoskeletal disorders, Primary sub-specialty: Musculoskeletal Pain Disorders
Conditions
Interventions
The study recruits hundred people in total: 25 patients with pain-prominent disease (from fibromyalgia populations), 25 patients with fatigue-prominent disease (from ME/Chronic Fatigue Syndrome popula
Sponsors
Brighton and Sussex University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be capable of giving informed consent 2. All participants must be aged 18 or over 3. Healthy controls – free from major medical or psychiatric illness 4. Patients – meet diagnostic criteria for Fibromyalgia and/or ME/Chronic Fatigue Syndrome; they will then be stratified into the above groups
Exclusion criteria
Exclusion criteria: All participants: 1. Not able to give informed consent 2. Age under 18 3. Needle phobia 4. MRI incompatibility 5. Presence of metal work (e.g pacemaker) in body 7. Claustrophobia 8. Inability to lie still for one hour 9. Pregnancy 10. Previous adverse reaction to Typhoid Vaccination Healthy controls: Major medical or psychiatric illness Patient participants: Major neurological illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effects of a systemic inflammatory challenge (typhoid injection) on human brain microstructure is measured using quantitative magnetization transfer (qMT) imaging at visit two or visit three (randomized). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain is measured using a Pain Visual Analogue Scale before and after the intervention at visit 1, 2, and 3 2. Fatigue is measured using a Fatigue Severity Scale before and after the intervention at visit 1, 2, and 3 3. Quality of life is measured using the 36-Item Short Form Survey (SF-36) at baseline at visit 1 4. Depression and anxiety is measured using the MINI diagnostic criteria at visit 1 5. Heart rate and blood pressure is measured using a non-invasive blood monitor during the autonomic function test at visit 1 6. Inflammatory markers are measured using blood tests at baseline at visit 1 and before and after the intervention at visit 2 and 3 7. Pressure Pain Thresholds are measured using an algometer before and after the intervention at visit 1, 2, and 3 8. Autonomic symptoms score is measured using the Autonomic Symptoms and Quality of Life Score at baseline 9. Cognition is measured using a Working Memory Assessment (subscale of WAIS-III) before and after the intervention at visit 1 and is measured using a short STROOP task at visit 2 and 3 10. Interoceptive function is measured using an interoceptive accuracy task (mental tracking) before and after the intervention at visit 1, 2, and 3 11. BOLD signal during fMRI is measured using a 3T scanner at visit 2 and 3. | — |
Countries
England, United Kingdom
Contacts
Public ContactJessica Eccles
Outcome results
None listed