NCT07637084 Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome (PBM-SEDh-01)
| NCT ID | NCT07637084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Medical ISM (Integrative Systemic Medicine) |
| Condition | Ehlers-Danlos Syndrome, Hypermobile |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2026-05-26 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07637084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ehlers-Danlos Syndrome, Hypermobile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07637084 currently recruiting?
Yes, NCT07637084 is actively recruiting participants. Contact the research team at dr.llessedjina@gmail.com for enrollment information.
Where is the NCT07637084 trial being conducted?
This trial is being conducted at Boulogne-Billancourt, France.
Who is sponsoring the NCT07637084 clinical trial?
NCT07637084 is sponsored by Centre Medical ISM (Integrative Systemic Medicine). The trial plans to enroll 25 participants.