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Clinical Trials/NCT02157389
NCT02157389CompletedNot Applicable

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

Central Institute of Mental Health, Mannheim2 sites in 1 country80 target enrollmentStarted: July 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
Changes in pain intensity and pain unpleasantness ratings after placebo intervention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Changes in pain intensity and pain unpleasantness ratings after placebo intervention

Time Frame: immediatey to one week

Secondary Outcomes

  • Changes in neuronal activity in response to painful stimulation after placebo administration(immediately)
  • Changes in movement abilities after placebo administration(immediately to one week)

Investigators

Sponsor
Central Institute of Mental Health, Mannheim
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof Herta Flor

Prof. Dr. Herta Flor

Central Institute of Mental Health, Mannheim

Study Sites (2)

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