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NCT07637084
Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome: A Prospective Observational Pilot Study
Conditions: Ehlers-Danlos Syndrome, Hypermobile Chronic Pain Fatigue
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 25
Sponsor: Centre Medical ISM (Integrative Systemic Medicine)
Location: Centre Médical ISM Boulogne-Billancourt Île-de-France Region
Summary
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
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
Source: ClinicalTrials.gov (NCT07637084). StuddyBuddy aggregates publicly available trial information.