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

Recruiting now

Conditions studied: Ehlers-Danlos Syndrome, Hypermobile, Chronic Pain, Fatigue Syndrome, Chronic

In brief

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.

Key facts

Study ID

NCT07637084

Run by

Centre Medical ISM (Integrative Systemic Medicine)

People needed

25

Starts

2026-05-26

Expected to finish

2027-09-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Follow-up at Centre Médical ISM, Boulogne-Billancourt
• Informed and non-opposition signed

You may not qualify if…

• Suspicious or malignant skin lesion on areas to be treated
• Non-modifiable photosensitizing treatment
• Pregnancy or breastfeeding
• Photosensitive epilepsy
• Acute articular inflammatory flare at inclusion date
• Analgesic treatment modification within 4 weeks prior to inclusion
• Simultaneous participation in another research protocol

Where it is running

• Centre Médical ISM — Boulogne-Billancourt, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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