Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome (PBM-SEDh-01)
RecruitingNCT07637084
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of MLS® Class IV Laser Photobiomodulation on Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome: A Prospective Observational Pilot Study in Private Medical Practice
- Conditions
- Ehlers-Danlos Syndrome, Hypermobile
- Chronic Pain
- Fatigue Syndrome, Chronic
- Sponsor
- Centre Medical ISM (Integrative Systemic Medicine)
- Start date
- 2026-05-26
- Primary completion
- 2027-03-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07637084