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CompletedNCT02157389Updated Jan 16, 2015

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

An interventional study of Administration of a pharmacological placebo in Chronic Lower Back Pain and Healthy Control Subjects, sponsored by Central Institute of Mental Health, Mannheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-16.

Sponsored by Central Institute of Mental Health, Mannheim · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Lower Back Pain
  • Healthy Control Subjects
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Central Institute of Mental Health, Mannheim is the lead sponsor of 59 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    placebo

    Administration of a pharmacological placebo (sodium chloride) via transdermal application to investigate the influence on pain perception in chronic back pain patients and to investigate the influence of attitude and experience with medication on the placebo effect

    Other: Administration of a pharmacological placebo

Interventions

  • OtherAdministration of a pharmacological placebo
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What researchers measure

Primary outcomes

  1. Changes in pain intensity and pain unpleasantness ratings after placebo intervention

    Time frame: immediatey to one week

Secondary outcomes

  1. Changes in neuronal activity in response to painful stimulation after placebo administration

    Time frame: immediately

  2. Changes in movement abilities after placebo administration

    Time frame: immediately to one week

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Study locations

1 site
  • Central Institute of Mental Health
    Mannheim, 68159, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02157389
Lead sponsor
Central Institute of Mental Health, Mannheim
Responsible party
Prof Herta Flor (Prof. Dr. Herta Flor, Central Institute of Mental Health, Mannheim) — Principal investigator
First posted
Jun 6, 2014
Start date
Jul 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 16, 2015

Study contacts

Herta Flor, PhD
principal investigator · Medical Faculty Mannheim, Heidelberg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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