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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Medical ISM (Integrative Systemic Medicine)

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

Trial groups

No trial groups listed