Clinical Trial of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measured Change in the Participants Pain Levels |
61.46; 19.79 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
The number of participants is projected to be thirty (30).
There will be an equitable distribution of male and female participants.
Women who are pregnant, trying to get pregnant, or nursing will be excluded from the study, as they should not receive Low-level Laser Therapy (LLLT). There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating such individuals.
The participants will be 18 years or older.
The ethnicity of the participants will be equitably distributed.
Inclusion criteria will be individuals that may benefit from an adjunctive therapy for musculoskeletal pain.
Exclusion Criteria
If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child.
Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device.
People suffering from infectious and acute disease such as a fever should not use this device.
People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device.
Person with a history of lentigines, an autoimmune vascular disease that causes color changes in the legs or arms due to obstruction or stenosis of blood vessels.
A person with a history of erythema, an acquired, long-lasting reticulocyte red and pigmented rash, caused by persistent or repeated exposure to intense heat or infrared radiation.
Persons who are susceptible to or have a history of herpes in the treatment area
Anyone who has experienced problems subsequent to previous laser treatments
People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device.
Use of laser light therapy in the ears, nose, eye, or throat is not recommended.
Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy.
Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy.
People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy.
Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy.
Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy.
Any insulin dependent individual should consult their physician before undergoing laser light therapy.
All individuals considered "vulnerable" such as children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity.
Data sourced from ClinicalTrials.gov (NCT06393088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.