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
The study is classified as a minimal risk trial of short duration therefore a detailed plan for monitoring the data for participant safety is not required.
Data Storage and Security
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.
Risk/Benefit Assessment
Applying the test for the determination of risk established by the FDA Regulation referred to as the "Common Rule" found in 45 Code of Federal Regulations (CFR) 46, Subpart A the rule states;
"Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The researchers have determined that only a minimal risk is presented to participants of the trial.
All persons interviewed for the trial will be selected using the established invisaRED Technologies IR REHAB guidelines for indications and contraindications. Combining the guidelines for indications and contraindications with the thorough classroom review and "hands on training " for clinicians who will be conducting the trial, the risk is best compared to exposure to sunlight.
Subjects of the study receiving the invisaRED Technologies IR REHAB therapy may receive the following benefits:
1. Open up blood vessels to ease swelling
2. Help the immune system create more chemicals that heal tissue
3. Build more connective tissue in injured area
4. Trigger endorphins, natural hormones that ease pain
5. Drug free therapy without a chance of addiction
6. The therapy is noninvasive
7. There are no known side effects
Subject Identification, Recruitment And Consent/Assent
At roadway intersections in close proximity to the research facility signs will be erected containing the verbiage: "Pain and Injury Study, No Cost, Call 770 988-5594" in order to recruit study volunteers from the community.
The clinic's primary care patients will also be provided an opportunity to volunteer for consideration as a trial participant.
The primary investigator will conduct all subject interviews and obtain informed consent. A thorough disclosure of all clinical process, contraindications, and any risk will be discussed with candidates for the trial.
There shall be no cost incurred by candidates for inclusion in the study or individuals selected to participate in the study.
No monetary remuneration will be offered participants in the study. However a commensurate number of treatments with the "as usual" IR REHAB device will be offered for free to those patients who received treatment using the sham device at the conclusion of the clinical trial. This will provide the participants treated with the sham device the opportunity to undergo therapy using an activated IR REHAB device.
Requirements for Human Subject Protection Training
The Primary Investigator and clinical associates conducting the trial will complete the Collaborative Institutional Training Initiative (CITI) course Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus).
