Clinical trial NCT05191511: Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin
Official title: Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Far- Infrared Burn
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Tainan Hospital, Ministry of Health and Welfare
First posted: 2022-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment of the Department of Traditional Chinese Medicine, Tainan Hospital, Ministry of Health and Welfare

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Body temperature of skin surface
timeFrame: 15 minutes
Secondary outcomes:
measure: Distance from IR lamp to skin
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Tainan Hospital, Ministry of Health and Welfare
state: West Central Dist
Study officials:
References: