Brain Imaging and Pain: Analysis of Placebo Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Brain Imaging of Placebo Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo Instructions

Intervention Type OTHER

There is no intervention in this study. It is not a Clinical Trial. The study is an investigation of the neural basis of placebo analgesia.

Control condition

The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.

Group Type ACTIVE_COMPARATOR

Control condition

Intervention Type OTHER

This protocol represents an investigation of the neural mechanisms of placebo analgesia. As such, it does not represent the traditional clinical trial design. Instead the "active" intervention is a placebo, and the comparison condition is a no-intervention control.

Interventions

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Placebo Instructions

There is no intervention in this study. It is not a Clinical Trial. The study is an investigation of the neural basis of placebo analgesia.

Intervention Type OTHER

Control condition

This protocol represents an investigation of the neural mechanisms of placebo analgesia. As such, it does not represent the traditional clinical trial design. Instead the "active" intervention is a placebo, and the comparison condition is a no-intervention control.

Intervention Type OTHER