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

NCT ID: NCT02157389

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

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.

Conditions

Chronic Lower Back Pain; Healthy Control Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Administration of a pharmacological placebo

Intervention Type: OTHER

Interventions

Administration of a pharmacological placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Prof Herta Flor

Prof. Dr. Herta Flor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herta Flor, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty Mannheim, Heidelberg University

Locations

Central Institute of Mental Health

Mannheim, , Germany

Countries

Germany

Other Identifiers

Fl156/33-1_chrBP

Identifier Type: -

Identifier Source: org_study_id