The Warmth, Anticipation, Sensation, Aversion, and Body-part Imaging Study
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrustees of Dartmouth College
About this trial
This functional magnetic-resonance imaging study of the brain will feature a within-subject crossover design to investigate the effects of a placebo cream on painful thermal stimulation rendered upon eight body sites. The investigators aim to 1.) improve the understanding of how the brain represents thermal pain responses somatotopically (i.e., across different body-sites) 2.) to test these brain representations with and without the presence of a pain-targeted placebo intervention, and 3.) to examine how these brain representations change prior to vs. during the delivery of thermal pain. They predict that placebo cream will downregulate the intensity of aversive brain activity representations, and to a lesser degree, sensation and somatotopic representations, both prior to and during painful thermal stimulation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject must be a volunteer with a minimum age of 18 years and must be able and willing to provide written informed consent.
If female, the subject must be non-lactating, not pregnant, and using a reliable contraception method.
Subject must be able to read and speak English.
Subject must be able to understand and follow the instructions of the investigator and understand all screening questionnaires.
Disqualifiers
If female, pregnancy.
Inability to tolerate the scanning procedures (e.g., claustrophobia).
Metal in body or prior history working with metal fragments (e.g., as a machinist).
Inability to tolerate heat pain applied to the forearm.
Trial design
Design model
Crossover
Treatments tested in this trial
Placebo Cream
BehavioralApproximately 1 teaspoon of exfoliating skin scrub delivered approximately 5 minutes prior to pain tasks will coincide with verbal descriptors of the cream as being analgesic.
Control Cream
BehavioralApproximately 1 teaspoon of exfoliating skin scrub delivered approximately 5 minutes prior to pain tasks will coincide with verbal descriptors of the cream as one of no effect.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Placebo Cream firstExperimental treatment 2 interventions
Group B: Control Cream firstExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Contrasts of pain valence (i.e., unpleasantness) using the Bartoshuk Labeled Magnitude Scale (LMS) between body sites administered Placebo vs. Control Cream, both prior to and during pain delivery.
Self-reported pain valence using the LMS ranging from 0-10 (with 0 representing "no pain" and 10 representing "most unlikable pain of any kind experienced".
Time frame
Hour 2 of fMRI scanning, immediately after each pain delivery trial.2
Contrast of pain intensity using the Bartoshuk Labeled Magnitude Scale (LMS) between body sites administered Placebo vs. Control Cream, both prior to and during pain delivery.
Self-reported pain intensity using the LMS ranging from 0-10 (with 0 representing "not intense" and 10 representing "most intense pain of any kind experienced".
Time frame
Hour 2 of fMRI scanning, immediately after each pain delivery trial.Secondary outcomes
1
Contrasts of activation of fMRI aversiveness signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
This will be collected with a Siemens 3T PRISMA.
Time frame
Hour 2 of fMRI scanning, immediately after each pain delivery trial.2
Contrasts of activation of fMRI sensation signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
This will be collected with a Siemens 3T PRISMA.
Time frame
Hour 2 of fMRI scanning, immediately after each pain delivery trial.3
Contrasts of activation of eight fMRI somatotopic signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
This will be collected with a Siemens 3T PRISMA. Eight signatures will include left and right masseter, left and right forearm, left and right calf, sternum, and abdomen.
Time frame
Hour 2 of fMRI scanning, immediately after each pain delivery trial.Other outcomes
1
Contrast of scalar activation of Neurologic Pain Signature between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
This will be collected with a Siemens 3T PRISMA.
Time frame
Hour 2 of fMRI scanning, immediately after each pain delivery trial.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov