Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome (PBM-SEDh-01)
NCT07637084 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25
Last updated 2026-06-15
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.
Conditions
- Ehlers-Danlos Syndrome, Hypermobile
- Chronic Pain
- Fatigue Syndrome, Chronic
Sponsors & Collaborators
-
Centre Medical ISM (Integrative Systemic Medicine)
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-26
- Primary Completion
- 2027-03-31
- Completion
- 2027-09-30
Countries
- France
Study Locations
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