Far- Infrared BurnNCT05191511
Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin
An observational study of Far- Infrared Burn, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Far- Infrared Burn
- What is being tested?
- Far- infrared
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment of the Department of Traditional Chinese Medicine, Tainan Hospital, Ministry of Health and Welfare
Who may be able to join
- Healthy adults over the age of 20 are not excluded from patients with lower back pain.
Who cannot join
- Exclude cardiovascular diseases, anemia, high blood pressure and other diseases that may affect circulation.
- People with skin diseases, skin allergies, and skin abnormalities.
- Patients who are clinically diagnosed with cancer or other major injuries.
- 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).
- Women who are pregnant or breastfeeding (positive urine pregnancy test).
- The moderator decides that it is not suitable to participate in this research.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tainan Hospital, Ministry of Health and Welfare
Tainan, West Central Dist, 70043
About this study
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
- Conditions
- Far- Infrared Burn
- Being tested
- Far- infrared
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far- infraredRadiation
safety of far- infrared
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature of skin surface
Local body temperature of skin surface
Measured: 15 minutes
Secondary outcomes (1)
Distance from IR lamp to skin
IR lamp to skin
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start4 Mar 2019
- Primary completion4 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Far- Infrared BurnStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191511
- Sponsor's protocol ID
- 20180101
- Status last verified
- Sep 2021
- First submitted
- 4 Oct 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin
- ClinicalTrials.gov ID
- NCT05191511
- Acronym / sponsor ID
- 20180101
- Conditions
- Far- Infrared Burn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of the Department of Traditional Chinese Medicine, Tainan Hospital, Ministry of Health and Welfare
Key inclusion criteria (1 listed)
- Healthy adults over the age of 20 are not excluded from patients with lower back pain.
Key exclusion criteria (6 listed)
- Exclude cardiovascular diseases, anemia, high blood pressure and other diseases that may affect circulation.
- People with skin diseases, skin allergies, and skin abnormalities.
- Patients who are clinically diagnosed with cancer or other major injuries.
- 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).
- Women who are pregnant or breastfeeding (positive urine pregnancy test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far- infraredsafety of far- infrared | Radiation | – |
Primary outcome
Body temperature of skin surface
Time frame: 15 minutes
Local body temperature of skin surface
1 secondary outcome
Distance from IR lamp to skin
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Far- Infrared Burn, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature of skin surface (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.