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
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.
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 →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.
Exclusion Criteria:
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
Changes in pain intensity and pain unpleasantness ratings after placebo intervention
Time frame: immediatey to one week
Changes in neuronal activity in response to painful stimulation after placebo administration
Time frame: immediately
Changes in movement abilities after placebo administration
Time frame: immediately to one week
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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Central Institute of Mental Health, Mannheim