Photobiomodulation for Chronic Pelvic Pain

(VOICE Trial)

This trial examines whether photobiomodulation, which uses near-infrared laser energy, can reduce chronic pelvic pain in women. Researchers are also assessing if it can alleviate pain during activities like standing, sitting, and urinating. Participants will receive either the actual laser treatment or a sham light therapy without laser energy. Women who have experienced pelvic pain for 3 months or more and find everyday activities significantly uncomfortable might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that react to heat or light. It's best to discuss your specific medications with the trial team.

Research has shown that light therapy using the SoLá Pelvic Therapy system is generally easy for people to handle. In one study, 60.9% of participants reported little to no pelvic pain after eight treatments. This indicates that the treatment is both effective and safe for most people. Furthermore, previous studies have not identified any major negative effects or harmful side effects, which supports its safety in humans.¹²³⁴⁵

Unlike standard treatments for chronic pelvic pain, which often rely on medications like pain relievers and hormone therapy, SoLa Pelvic Therapy uses a unique method called photobiomodulation. This technique involves applying near-infrared light (810-980nm) to the vaginal area, which may offer pain relief by stimulating cellular repair and reducing inflammation without medication. Researchers are excited because this non-invasive approach could provide a new option for patients seeking relief without the side effects associated with traditional drugs. Moreover, the trial includes a sham-light group to rigorously test the effectiveness, adding credibility to any positive outcomes.

Research has shown that SoLá Pelvic Therapy, which uses a special type of light therapy, can significantly reduce chronic pelvic pain. One small study found that 60.9% of participants reported little to no pelvic pain after eight treatments, compared to just 27% at the beginning. This trial will compare the effects of Vaginal photobiomodulation, which uses near-infrared light energy, with a Sham-Light treatment that does not use focused laser energy. The therapy relaxes tight pelvic muscles that often cause pain, and the light energy helps trigger the body's natural healing processes. Early results suggest this method can help reduce pain during activities like standing, sitting, and even during intercourse.¹²³⁴⁵