The power of expectation:Effects of an open-label placebo intervention on pain processing and learned anticipation - an experimental fMRI study in fibromyalgia syndrome
- Conditions
- M79.7Fibromyalgia
- Registration Number
- DRKS00033698
- Lead Sponsor
- Ruhr-Universität Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 120
FMS: confirmed diagnosis of fibromyalgia syndrome;
All participants: BMI 18-30kg/m2
All participants: inflammatory, neuropathic or tumor pain; insufficient knowledge of German; noticeable cognitive impairments; limited legal capacity or custody by official order; use of opioids or sedatives; medication or drug dependence or abuse; illnesses that prevent lying quietly in the examination device for approx. 90 minutes (e.g. excessive pain, claustrophobia); metal parts or electrically working health aids in the body; large tattoos with metal particles
Healthy participants additionally: any acute or chronic physical illnesses; acute and chronic psychiatric diagnoses according to DSM-IV
Patients: acute or chronic physical illnesses other than FMS; severe psychiatric diagnoses according to DSM-IV (e.g. schizophrenia, bipolar disorder)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of intensity of somatic pain stimuli before and after OLP intervention; assessment of aversive somatic and acoustic stimuli and visual predictive cues before and after classical fear conditioning (intensity, valence and fear); neural correlates during anticipation and experience of experimental pain stimuli
- Secondary Outcome Measures
Name Time Method Daily assessment of well-being, mood and treatment expectations using EMA during the intervention week; collection of salivary cortisol and state anxiety as markers of acute stress and arousal daily during the intervention week and at several time points during the experimental days