The Neurobiology of Expectancy and Pain Perception

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Heat pain applied using TSA or CHEPS

• Registration Number: NCT01575106
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how contextual learning/expectation relieves or aggravates pain experience in the same cohort of subjects and the same study session.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-11
• Study Start: 2012-06
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-01
• Results First Submitted: 2017-01-06
• Results First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Results First Posted: 2017-10-13
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• a) Healthy male and female adults aged 21-50
• b) No contraindications to fMRI scanning
• c) Right handed

Exclusion Criteria

• a) Current or past history of major medical, neurological, or psychiatric illness
• b) Pregnancy or breast feeding, menopause, and irregular menstrual cycles (length of cycle must be within 26 to 32 days)
• c) Claustrophobia
• d) History of head trauma
• e) History of impaired elimination
• f) Instability of responses to experimental pain (see Study Procedures Section)
• g) Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
• h) Non-fluent speaker of English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Heat pain applied using TSA or CHEPS	There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.

Primary Outcome Measures

Name	Time	Method
Subjective Response to Pain (0-20 Visual Analogue Scale)	Weeks 1-3	Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.
fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex	Week 4	We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States