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

Chronic Lower Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157389
• Other study ID #: Fl156/33-1_chrBP
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: January 15, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Back Pain
• Chronic Lower Back Pain
• Healthy Control Subjects
• Low Back Pain

Intervention

Other:
• Administration of a pharmacological placebo

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain intensity and pain unpleasantness ratings after placebo intervention		immediatey to one week	No
Secondary	Changes in neuronal activity in response to painful stimulation after placebo administration		immediately	No
Secondary	Changes in movement abilities after placebo administration		immediately to one week	No