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| Name | Class |
|---|---|
| Soovu Labs Inc. | INDUSTRY |
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We hope to assess the safety of a recurrent heating device for pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heating Device Application | Experimental | Heating devices will be applied to the trunk and extremities of the body. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heating device (Heatwave Technology) | Device | Heating devices will be applied to the trunk and extremities of the body during the first study visit. During each heating cycle, the temperature will increase quickly from room temperature to a high of 45C and then cycle back down. Each heating cycle is 30 minutes with a 3 minute cool down period where no heat is applied. The maximum temperature used in this study is 45 degrees C (113 degrees F). There will be a total of 3 heating cycles at the visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain - Visual Analog Scale | Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain | 100 minutes |
| Erythema (skin redness) | Measured with skin colorimeter | 100 minutes |
| Post-inflammatory hyperpigmentation | Measured with skin colorimeter | 100 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mood and Anxiety Assessment | Survey based measure using Likert scale responses | 100 minutes |
| Mood and Anxiety Assessment | Survey based measure using Likert scale responses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Maloh, ND | Contact | 9167502463 | jessica@integrativeskinresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95819 | United States |
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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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| 1 week |
| Pain - Visual Analog Scale | Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain | 1 week |
| Erythema (skin redness) | Measured with skin colorimeter | 1 week |
| Post-inflammatory hyperpigmentation | Measured with skin colorimeter | 1 week |