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Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain

Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02157389
Enrollment
80
Registered
2014-06-06
Start date
2012-07-31
Completion date
2014-12-31
Last updated
2015-01-16

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

Conditions

Chronic Lower Back Pain, Healthy Control Subjects

Brief summary

Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological rather than psychological interventions. Moreover, only few studies examined patients or tested how previous experience and attitudes affect placebo and nocebo responses. On the psychological level expectancy and classical conditioning have been identified as two primary mechanisms. Both seem to be important with classical conditioning potentially having more long-term effects and expectancy being more important in nocebo effects. There is some initial evidence from the investigators own research that patients may be more prone to these effects and the investigators have also shown that placebo effects may last up to several years after treatment. The investigators therefore examine previous attitudes to pharmacological interventions for chronic pain in patients with chronic back pain and subdivide them into groups with high of low belief in the respective treatment modality. The investigators then apply a pharmacological placebo and study the interaction between the prevailing attitude (implicit and explicit) and the placebo effect with respect to pain perception but also to neurobiological mechanisms using functional magnetic resonance imaging. In addition to expectancy, conditioning of placebo will be examined and the long-term effects of the intervention will be determined.

Interventions

OTHERAdministration of a pharmacological placebo

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and female human subjects with chronic back pain (chronic persistent and recurrent pain \> 6 months) * Age between 18 and 65 * Voluntary participation.

Exclusion criteria

* Acute or chronic somatic diseases and inflammatory, neuropathic or tumor-related pain * Acute and chronic mental disorders according to DSM-IV (except for comorbid anxiety or depression, which are frequent in chronic pain) * Insufficient German language skills * Cognitive limitations * Intake of opioid medication or tranquilizers * Metal implants or electric implants that cannot be removed * Pregnancy * Claustrophobia * History of epilepsy, brain trauma, or brain tumor

Design outcomes

Primary

MeasureTime frame
Changes in pain intensity and pain unpleasantness ratings after placebo interventionimmediatey to one week

Secondary

MeasureTime frame
Changes in neuronal activity in response to painful stimulation after placebo administrationimmediately
Changes in movement abilities after placebo administrationimmediately to one week

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026