Safety of Pulsing Heating Device Use on the Skin

Not Applicable

• Conditions: Pain
• Interventions: Device: Heating device (Heatwave Technology)

• Registration Number: NCT05427877
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

We hope to assess the safety of a recurrent heating device for pain relief.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-19
• Last Update Submitted: 2022-06-19
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heating Device Application	Heating device (Heatwave Technology)	Heating devices will be applied to the trunk and extremities of the body.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pain - Visual Analog Scale	1 week	Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain
Mood and Anxiety Assessment	1 week	Survey based measure using Likert scale responses
Erythema (skin redness)	1 week	Measured with skin colorimeter
Post-inflammatory hyperpigmentation	1 week	Measured with skin colorimeter

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States