Laser Therapy Cleared to Treat Pain Associated With Fibromyalgia

The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study.

The Food and Drug Administration (FDA) has granted 510(k) clearance to FibroLux laser for adjunctive use in temporary relief of pain associated with fibromyalgia.

FibroLux is a laser based therapy that delivers optimal doses of light energy using a combination of curated wavelengths. The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study (ClinicalTrials.gov Identifier: NCT04322812) that included 90 patients with fibromyalgia. Patients were randomly assigned 1:1 to receive either FibroLux or sham 3 times a week for a total of 9 treatment sessions over a 3-week period. 

Findings showed that a greater proportion of patients treated with FibroLux had a clinically meaningful and statistically significant decrease in tender point count (TPC of 20% or greater) compared with those who received placebo (primary endpoint; 86.67% vs 48.89%, respectively; treatment difference, 37.78%; P <.0005).

The mean decrease in TPC from baseline was reported to be 8.00 points in the FibroLux group and 2.71 points in the placebo group. Fibrolux was also associated with a 35.79 point decrease in mean total score on the Fibromyalgia Impact Questionnaire compared with a 20.83 point decrease for placebo. Additionally, mean pain ratings on the 0-100 Visual Analog Scale decreased 42.84 points for the FibroLux arm and 17.98 points for the placebo arm (treatment difference, 24.86 points). 

“Laser therapy has been a game-changer in the rehabilitation and pain management space for years,” said Multi Radiance Medical CEO Max Kanarsky. “Now, as the first laser company to achieve a patent and FDA clearance for relief of fibromyalgia pain, this opens the door for how to effectively manage this tough condition.”

References

  1. Multi Radiance Medical therapeutic laser receives FDA clearance for the treatment of pain associated with fibromyalgia. News release. Multi Radiance Medical. Accessed October 4, 2022. https://www.businesswire.com/news/home/20221004005022/en/Multi-Radiance-Medical-Therapeutic-Laser-Receives-FDA-Clearance-for-The-Treatment-of-Pain-Associated-with-Fibromyalgia
  2. Medical devices: product classification. US Food and Drug Administration. Accessed October 4, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=5460
  3. Demchak T, Leal-Junior EC. A photoceutical approach to treating fibromyalgia: A scientific monograph. Multi Radiance Medical. Laser Therapy University. 

This article originally appeared on MPR