About this trial
This study evaluates the effect of photobiomodulation (PBM) therapy using a MLS® class IV laser on chronic pain and fatigue in patients with hypermobile Ehlers-Danlos Syndrome (hEDS). hEDS is a hereditary connective tissue disorder characterized by joint hypermobility, chronic pain, and debilitating fatigue, for which therapeutic options remain limited.
Participants will receive 10 PBM sessions over 5 weeks (2 sessions per week), using red and near-infrared light (808 nm continuous + 905 nm pulsed) applied to painful areas identified at baseline. Pain (Visual Analogue Scale), multidimensional fatigue (MFI-20), and quality of life (EQ-5D-5L) will be assessed at baseline (T0), end of treatment (week 5), and follow-up (week 10).
This is a pilot observational study - the first to document the effect of MLS® laser PBM in hEDS. No additional procedures beyond routine care are required.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Confirmed diagnosis of hypermobile Ehlers-Danlos Syndrome (hEDS) according to 2017 International Consortium criteria
Chronic pain ≥ 3 months, average VAS score ≥ 4/10 over the preceding week
Stable analgesic treatment for ≥ 4 weeks (if any)
Disqualifiers
Suspicious or malignant skin lesion on areas to be treated
Non-modifiable photosensitizing treatment
Pregnancy or breastfeeding
Photosensitive epilepsy
Trial design
Treatments tested in this trial
- Not listed