Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin

Abstract The equipment "infrared therapeutic device" is widely used in various medical institutions in Taiwan. The infrared therapeutic device improves the blood circulation, relieves muscle stiffness and pain by the heat energy radiated by the infrared light, and has a significant relief effect on patients with joint pain, muscle soreness, and back discomfort. However, the principle of the infrared therapeutic device is thermal energy, and there is no complete literature on the parameters such as treatment intensity and time and the full distance. In addition, the literature on the damage that can be caused is not based on clinical evidence, and there is no standardization study on the use of equipment, so it is hoped that this test will explore the safety distance of infrared therapeutic devices.

The project is expected to recruit 50 people from 20 years old to 75 years old in the Chinese Medicine Clinic of Tainan Hospital of the Ministry of Health and Welfare, which is included in the diagnosis of osteoarthritis, degenerative arthritis, osteoporosis and other related Chinese medicine clinics. In patients with diseases, the main complaint must include patients with lower back pain and back pain. Subjects should exclude diseases that may be affected by chemoradiotherapy, cardiovascular disease, anemia, hypertension, etc., and exclude dermatitis, skin irritation, and erythema. Skin diseases such as lupus. The test site is the TCM clinic of Tainan Hospital of the Ministry of Health and Welfare. The air conditioner is fixed at a constant temperature of 28 degrees. The output power is calculated by the wattage meter, and the distance and temperature of the infrared lamp are measured. Finally, the appropriate temperature and distance of the infrared lamp to the human skin are estimated through calculation.

Keywords: Infrared, Far- infrared, Burn

Study Overview

• Status: Completed
• Conditions: Far- Infrared Burn
• Intervention / Treatment: Radiation: Far- infrared

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Taiwan
  • West Central Dist
    • Tainan, West Central Dist, Taiwan, 70043
      • Tainan Hospital, Ministry of Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Recruitment of the Department of Traditional Chinese Medicine, Tainan Hospital, Ministry of Health and Welfare

Description

Inclusion Criteria:

• Healthy adults over the age of 20 are not excluded from patients with lower back pain.

Exclusion Criteria:

1. Exclude cardiovascular diseases, anemia, high blood pressure and other diseases that may affect circulation.
2. People with skin diseases, skin allergies, and skin abnormalities.
3. Patients who are clinically diagnosed with cancer or other major injuries.
4. Excluded conditions are alcoholics, diabetic patients (blood sugar greater than or equal to 200 mg/dL), and severe or life-threatening complications (determined by the trial host based on medical history).
5. Women who are pregnant or breastfeeding (positive urine pregnancy test).
6. The moderator decides that it is not suitable to participate in this research.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature of skin surface	Local body temperature of skin surface	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance from IR lamp to skin	IR lamp to skin	15 minutes

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: Tainan Hospital, Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2019
• Primary Completion (ACTUAL): November 4, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (ACTUAL): January 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 2, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20180101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No