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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat pain applied using TSA or CHEPS | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Kong, MD,eq/MS/MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heat Pain | There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS. 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heat Pain | There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS. 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | Weeks 1-3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heat Pain | All subjects receive the same intervention, the application of heat pain using TSA or CHEPS. 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin and tissue disorders | Skin and subcutaneous tissue disorders | itching, tenderness, and burning |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jian Kong | Massachusetts General Hospital | 617-726-7893 | JKONG2@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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). | The neutral cream is omitted from the data table below because we were only concerned about the direct comparison between positive expectancy ("Lidocaine") and negative expectancy ("Capsaicin") conditions. Data were only collected for the Lidocaine and Capsaicin creams. | Posted | Mean | Standard Deviation | Post-Pre treatment peak beta | Week 4 |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 1 |
| 38 |
| EG001 | Cream | All subjects were told they would receive lidocaine, capsaicin, and neutral cream on their forearm, but in reality they only received neutral cream (regular moisturizing lotion). | 0 | 38 | 0 | 38 | 0 | 38 |
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