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Clinical Trials/NCT01575106
NCT01575106
Completed
Not Applicable

A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin

Massachusetts General Hospital1 site in 1 country38 target enrollmentJune 2012
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Massachusetts General Hospital
Enrollment
38
Locations
1
Primary Endpoint
Subjective Response to Pain (0-20 Visual Analogue Scale)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
October 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jian Kong

Assistant Professor

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Subjective Response to Pain (0-20 Visual Analogue Scale)

Time Frame: 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

Time Frame: 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).

Study Sites (1)

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