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On October 4th local time, a press release from Multi Radiance Medical (MRM) said that U.S. Food and Drug Administration (FDA) has approved FibroLux laser treatment device for the treatment of pain symptoms in patients with fibromyalgia. This approval indicates that a non-invasive, non-pharmacological treatment method will be added to the treatment of fibromyalgia pain - laser.
MRM said that FibroLux laser therapy equipment uses a photochemical method for treatment. clinical trial found that FibroLux reduced the tender point count in patients compared to placebo, lowering the mean pain score and the fibromyalgia impact questionnaire (FIQR) score .
A prospective, placebo-controlled, randomized, double-blind , parallel group, multicenter trial, based on the set study endpoint (the proportion of patients with reduced tender point counts from baseline is clinically significant and statistically significantly reduced by ≥20%) evaluated the differences between the treatment and control groups. In the end, 86.7% of patients in the FibroLux group reached the study endpoint, while this proportion was only 48.89% in the placebo group (P <>FibroLux provides a safe and effective treatment method to alleviate the painful symptoms of fibromyalgia, and the average treatment time is short, only lasting 3-6 minutes.
Reference source:
1.Shenaz Bagha.FDA clears laser therapy to treat fibromyalgia pain. https://www.healio.com/news/rheumatology/20221005/fda-clears-laser-therapy-to-treat-fibromyalgia-pain
2.Multi Radiance Medical Therapeutic Laser Receives FDA Clearance for The Treatment of Pain Associated with Fibromyalgia | Business Wire
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