DRKS00027130RecruitingPhase 3
Expectation management and open label placebo: Novel approaches to improve treatment outcome of pain and gluten intolerance in patients with fibromyalgia
niversitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Anästhesiologie, Schmerzmedizin und Schmerzpsychologie0 sites100 target enrollmentStarted: March 17, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •Diagnosis of fibromyalgia syndrome;
- •minimum age 18 years
- •sufficient knowledge of the German language
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)
Investigators
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