Pain
Conditions
Brief summary
We hope to assess the safety of a recurrent heating device for pain relief.
Interventions
DEVICEHeating device (Heatwave Technology)
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.
Sponsors
Soovu Labs Inc.
Integrative Skin Science and Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain - Visual Analog Scale | 100 minutes | Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain |
| Erythema (skin redness) | 100 minutes | Measured with skin colorimeter |
| Post-inflammatory hyperpigmentation | 100 minutes | Measured with skin colorimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood and Anxiety Assessment | 100 minutes | Survey based measure using Likert scale responses |
| Post-inflammatory hyperpigmentation | 1 week | Measured with skin colorimeter |
| Pain - Visual Analog Scale | 1 week | Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain |
| Erythema (skin redness) | 1 week | Measured with skin colorimeter |
Countries
United States
Contacts
Primary ContactJessica Maloh, ND
Outcome results
None listed