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The power of expectation: Effects of an open-label placebo intervention on pain processing and learned anticipation - an experimental fMRI study in fibromyalgia syndrome

The power of expectation: Effects of an open-label placebo intervention on pain processing and learned anticipation - an experimental fMRI study in fibromyalgia syndrome - FibrOLPain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033698
Enrollment
120
Registered
2024-02-26
Start date
2024-05-02
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M79.7

Interventions

Group 1: Patients with fibromyalgia syndrome (OLP-FMS) Pain threshold determination and experimental pain paradigm with heat pain stimuli
video-based OLP instruction with subsequent OLP intervention under telemedical support (Medication Event Monitoring System, MEMS and Ecological Momentary Assessment, EMA)
after 1-week intervention repeated pain threshold determination and experimental pain paradigm with heat pain stimuli, associative learning paradigm with nociceptive heat stimuli and non-nociceptive a
video-based OLP instruction with subsequent control condition under telemedical support (Ecological Momentary Assessment, EMA)
after 1-week control treatment, repeated pain threshold determination and experimental pain paradigm with heat pain stimuli, associative learning paradigm with nociceptive heat stimuli and non-nocicep
after 1-week control treat

Sponsors

Ruhr-Universität Bochum
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: FMS: confirmed diagnosis of fibromyalgia syndrome; All participants: BMI 18-30kg/m2

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactMartin Diers

Ruhr-Universität Bochum

martin.diers@ruhr-uni-bochum.de+49 234 5077 3175

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026