Safety of Pulsing Heating Device Use on the Skin

Study Overview
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Brief Summary
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We hope to assess the safety of a recurrent heating device for pain relief.

Official Title
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Safety of Pulsing Heating Device Use on the Skin

Conditions
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Pain

Intervention / Treatment
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* Device: Heating device (Heatwave Technology)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals in good general health. No known medical conditions that, in the investigator's opinion, may interfere with study participation. Subjects 18 year of age and older. Exclusion Criteria: Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator. Individuals with peripheral neuropathy or a neuropathic condition that would alter their ability to sense pain. Individuals with clinically significant unstable medical disorders that would disqualify the participant at the discretion of the investigator. Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator. Women who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heating Device Application<br>Heating devices will be applied to the trunk and extremities of the body. | Device: Heating device (Heatwave Technology)<br>* 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.<br>* Other names: Soovu heating devices (Heatwave Technology);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |