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Clinical Trials in France / NCT07637084
Recruiting Observational

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

NCT07637084 · tracked via the Priya Life Science France tracker
Sponsor
Centre Medical ISM (Integrative Systemic Medicine)
Phase
Observational
Started
2026-05-26
Last updated
2026-06-15

Condition(s) studied

Ehlers-Danlos Syndrome, HypermobileChronic PainFatigue Syndrome, Chronic

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre Médical ISM Boulogne-Billancourt Île-de-France Region Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07637084 on ClinicalTrials.gov ↗ ← All trials in France