M79.7 F45.41
Conditions
Interventions
Group 1: Patients with fibromyalgia start with a gluten-free diet for 10 days. The patients then receive a porridge containing gluten along with a positively instructed open-label placebo (positive ef
Sponsors
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Anästhesiologie, Schmerzmedizin und Schmerzpsychologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of fibromyalgia syndrome; minimum age 18 years sufficient knowledge of the German language
Exclusion criteria
Exclusion criteria: • Diagnosis of gluten-sensitive enteropathy or wheat allergy, or abnormal blood results during screening; • Severe acute or chronic mental health condition (e.g., psychosis, severe depression); • Presence of active chronic gastrointestinal disease requiring acute or other treatment; • Presence of other active pain disorders with a dominant role in pain symptoms, requiring acute or other treatment; • Current condition of pregnancy or breast-feeding; • Current treatment with anti-inflammatory medication (which might influence the experimental serum parameters) • Patients with galactose-intolerance, lactase deficiency or glucose-galactose-malabsorption • Allergy against ingredients of porridge (Nestle BEBA Sinlac, rice flakes, fructose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in pain before and after open-label placebo treatment and during gluten provocation measured by pain diary (numeric rating scale 0-10). | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in symptoms of gluten intolerance and mobility before and after open-label placebo treatment and during gluten provocation measured by pain and well-being inventory as well as inflammation-, and pain-specific parameters measured by blood analysis | — |
Countries
Germany
Contacts
Public ContactLena Paschke
Universitätsklinikum Hamburg-EppendorfZentrum für Anästhesiologie und Intensivmedizin
Outcome results
None listed