Pilot Observational Study of MLS4 Laser Photobiomodulation Therapy for Chronic Pain and Fatigue in Adults with Hypermobile Ehlers-Danlos Syndrome

What this Trial Is About

Researchers are evaluating the effects of photobiomodulation PBM therapy using a MLS4 class IV laser on chronic pain and fatigue in adults with hypermobile Ehlers-Danlos Syndrome hEDS. hEDS is a hereditary connective tissue disorder marked by joint hypermobility, persistent pain, and severe fatigue, with limited treatment options. This pilot observational study is the first to document the impact of MLS4 laser PBM in this condition, conducted without altering ongoing treatments or adding procedures beyond usual care. Participants will undergo 10 PBM therapy sessions over 5 weeks, receiving two sessions per week. The treatment uses red and near-infrared light 808 nm continuous and 905 nm pulsed applied to up to 3-4 painful areas identified at the start. The laser fluence gradually increases from 4 to 8 Jcmb2 over sessions. No control group or randomization is involved, and the study is conducted at a single center. During the study, pain intensity will be measured using the Visual Analogue Scale, along with assessments of multidimensional fatigue and quality of life at baseline, after treatment week 5, and at follow-up week 10. No extra procedures beyond routine care are needed. The study aims to observe changes in pain and fatigue durability, with participant involvement lasting approximately 10 weeks from baseline assessment to follow-up.

Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome (PBM-SEDh-01)