The Neurobiology of Expectancy and Pain Perception

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575106
• Other study ID #: 2011P000663
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: September 12, 2017
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Heat pain applied using TSA or CHEPS
TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Response to Pain (0-20 Visual Analogue Scale)	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.	Weeks 1-3
Primary	fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex	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).	Week 4