Photobiomodulation for chronic pain and fatigue in hypermobile Ehlers-Danlos syndrome
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
Run by Centre Medical ISM (Integrative Systemic Medicine) · NCT07637084 · Data updated 2026-11-12
This pilot observational study tests whether MLS laser photobiomodulation can reduce chronic pain and fatigue in adults with hypermobile Ehlers-Danlos syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Centre Medical ISM (Integrative Systemic Medicine) Academic / other |
| Locations | 1 site (Boulogne-Billancourt, Île-de-France Region) |
| Status | Recruiting |
| Started | May 26, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07637084 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed hEDS diagnosis, chronic pain for at least 3 months, and stable analgesic therapy.
✕Probably not a fit
Patients who do not respond to PBM or who experience no change in pain or fatigue may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-center, prospective pilot study, adults with hEDS and chronic pain will receive 10 photobiomodulation sessions over 5 weeks using an MLS® class IV laser. Treatments target pain-identified areas with red and near-infrared light at increasing fluence levels. Outcomes include pain on a visual scale, fatigue (MFI-20), and quality of life (EQ-5D-5L) assessed at baseline, week 5, and week 10. The study uses a paired, non-randomized design with no control group and will analyze data descriptively and with Wilcoxon signed-rank tests. It aims to document feasibility and potential signals of benefit for this treatment approach in hEDS.
Why it matters
Potential benefit: If successful, patients may experience reductions in pain and fatigue and improvements in daily functioning.
How similar studies have gone: This is one of the first studies to examine MLS® laser PBM in hEDS; prior evidence for this specific approach is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Centre Médical ISM
Boulogne-Billancourt, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Lilian Lessedjina, M.D.
- Email: dr.llessedjina@gmail.com
- Phone: +337-82-83-40-83
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.