The Neurobiology of Expectancy and Pain Perception
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|ClinicalTrials.gov Identifier: NCT01575106|
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Heat pain applied using TSA or CHEPS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Arm 1
There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.
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)
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575106
|United States, Massachusetts|
|Massachusetts General Hospital|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Jian Kong, MD,eq/MS/MPH||Massachusetts General Hospital|