Clinical Trial to Establish the Safety and Efficacy of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Measured Change in the Participants Pain Levels
研究概览
简要总结
This is a trial to measure the effectiveness and safety of the invisa-RED® IR REHAB device. The researchers will compare the muscle and joint pain relief of participants who are treated with the real machine, to those treated with a non-working "look-a-like" device. If there is a significant difference of pain relief between those treated with the real machine and those treated with the 'look-a-like' device and no safety issues are discovered, the researchers will be able to assume the IR REHAB device is safe and effective for the treatment of muscle and joint pain.
详细描述
Clinical Trial to Establish the Safety and Efficacy of the IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain
Purpose of the Study
The trial is designed to provide data with which to evaluate the efficacy and safety of the invisa-RED® IR REHAB Low-level Laser Therapy (LLLT) device as compared with a sham device when used for the adjunctive treatment of musculoskeletal pain . This will be a single blind trial of two groups of equal number; one group will be treated as usual, the other treated using a sham device. At the conclusion of the trial; results from the two groups will be statistically analyzed to determine the efficacy of the IR REHAB machine for the adjunctive treatment of musculoskeletal pain .
"Musculoskeletal pain is a challenging condition for both patients and physicians. Many adults have experienced one or more episodes of musculoskeletal pain at some time of their lives, regardless of age, gender, or economic status. It affects approximately 47% of the general population. Of those, about 39-45% have long-lasting problems that require medical consultation. Inadequately managed musculoskeletal pain can adversely affect quality of life and impose significant socioeconomic problems."
Monitoring Plan
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
All individuals participating in the trial will be assigned a participant number. Subsequently all clinical records and reports will reference only the participant number, ensuring that participants remain anonymous.
Because of the low number of trial participants, only paper records will be maintained for all clinical and personal data. Records will be kept in locked storage and physical access will only be on a need to know basis. A participants' personal data correlating the participating individuals name and the trial participants Identifying Number will only be available to the principal investigator, clinical staff, and the trial administrator. All analytics will be performed on securely encrypted devices using only data masked or redacted of any personal information.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Measured Change in the Participants Pain Levels
时间窗: Participants pain levels will be recorded over a period of three weeks.
Participants pain levels will be measured using a visual analog scale of 0-100mm where a smaller number indicates a lower perceived pain level and a larger number indicates a higher level of pain. The participant will personally manipulate a visual analog scale with a manual slide indicator to record their pain levels
次要结局
未报告次要终点