jeudi 3 janvier 2019

Discovering FDA Approved Laser For Pain

By Sandra Cole


When it comes to those whom suffer from painful areas of the body that are so intense medication or treatment is necessary, there is good news. For, in June of 2018, the FDA approved laser for pain elimination in the United States. Having cleared the Multi Radiance Medical's MR4 Laser for relief of pain in the shoulder and neck.

For after a series of studies with test subjects using an actual product while others used a placebo, there was enough proof in the safety and effectiveness of a new laser that it received approval from the United States Food and Drug Administration. In addition, the product has also received a NHN product classification with FDA clearance which now allows for the use of the product by individuals and clinicians.

The product emits monochromatic radiation by using light amplification which is coherent and collimated. The process emits energy through wavelengths of infrared or other sources which provide a non-thermal and non-heated effect. In all cases, the product can be used without the need for associated topical or other forms of heat.

While a number of similar products are for sale in the United States, few have obtained FDA approval or have been designated as NHN which recognizes the product as being non-thermal. As such, while a number of the products may be effective, most are lacking the safety requirements of those approved by the FDA.

In most cases, companies avoid undergoing FDA approval due to the costly and rigorous process to do so. For, the process involves conducting studies and reporting results to a number of organizations. After which, the product must also undergo a number of tests to support claims related to effectiveness and safety.

Unlike many companies whom mass produce these products, multi radiance super pulsed lasers are produced using innovative technology which delivers direct light energy to tissue increasing circulation and relieving discomfort. In doing so, the light includes wavelengths which allow for better absorption and deeper penetration. As a result, the discomfort is often eliminated for a much longer period of time than when taking medication or obtaining chiropractic adjustments.

During the study, researchers worked with 86 individuals to investigate how phototherapy and other light therapies effected nonspecific painful areas of the knee. The results of 12 treatments showed that this new technology had better results than chiropractic care, physical therapy or conventional treatment. After which, the participants underwent assessments to determine whether or not pain had lessened or intensified during a one month follow up.

Once having discovered the pain had eased or subsided completely, researchers were fairly sure that FDA approval would be granted. While this is the case, there were also additional studies necessary to determine the safety and effectiveness of the new light based laser therapy on the neck and shoulder of other subjects before approval could be finalized. Once those results also showed positive results, FDA approval was granted, thus allowing clinicians and individuals to relieve pain without harsh narcotics, multiple trips to a chiropractor or painful cortisone injections.




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