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

Recruitingn/aAges 18 Years - anyAllCentre Medical ISM (Integrative Systemic Medicine)
NCT07637084 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
Centre Médical ISM
Boulogne-Billancourt, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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