Brain Imaging and Pain: Analysis of Placebo Analgesia

Phase 1

Completed

• Conditions: Brain Imaging of Placebo Analgesia
• Interventions: Other: Placebo Instructions; Other: Control condition

• Registration Number: NCT01409538
• Lead Sponsor: University of Florida

Brief Summary

This study examines the brain activation associated with placebo pain reduction.

Detailed Description

This study is a basic science study of the mechanisms of placebo analgesia in asymptomatic healthy individuals. Each participant receives a baseline pain testing session, followed by a conditioning paradigm that results in expectation of pain relief and conditioning. They then undergo functional magnetic resonance imaging during either placebo (conditioned analgesia) or baseline. To examine order effects and habituation, the participants also either undergo a repeated placebo or a repeated baseline. The primary dependent measures in the study are the fMRI determined regions of interest, in a network of brain areas associated with pain processing. The anticipated outcome of the study is the alteration of network connectivity between sensory, affective, evaluative areas of the brain associated with placebo.

Because this is not a traditional clinical trial, there are not traditional efficacy criteria, rather the outcomes are changes in brain function from manipulations of patient expectation and classical conditioning.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• at least 18 years of age
• english speaking

Exclusion Criteria

• pain condition
• pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Instructions	Asymptomatic control participants receive Natural History and Placebo instructions in a within-subject design. There are no patients, or active agents in this study. It is not a Clinical Trial.
Control condition	Control condition	The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.

Primary Outcome Measures

Name	Time	Method
Brain Imaging Results	2 weeks from baseline	This outcomes represents the neural network underpinnings of the placebo analgesic response. It is the result of a network analysis using structural equation modeling of fMRI determined brain activations.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States