Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain
Primary Purpose
Chronic Lower Back Pain, Healthy Control Subjects
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Administration of a pharmacological placebo
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Lower Back Pain
Eligibility Criteria
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
Sites / Locations
- Central Institute of Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Changes in pain intensity and pain unpleasantness ratings after placebo intervention
Secondary Outcome Measures
Changes in neuronal activity in response to painful stimulation after placebo administration
Changes in movement abilities after placebo administration
Full Information
NCT ID
NCT02157389
First Posted
June 3, 2014
Last Updated
January 15, 2015
Sponsor
Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT02157389
Brief Title
Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain
Official Title
Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Institute of Mental Health, Mannheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Back Pain, Healthy Control Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Administration of a pharmacological placebo
Primary Outcome Measure Information:
Title
Changes in pain intensity and pain unpleasantness ratings after placebo intervention
Time Frame
immediatey to one week
Secondary Outcome Measure Information:
Title
Changes in neuronal activity in response to painful stimulation after placebo administration
Time Frame
immediately
Title
Changes in movement abilities after placebo administration
Time Frame
immediately to one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herta Flor, PhD
Organizational Affiliation
Medical Faculty Mannheim, Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain
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