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

Sponsor
Centre Medical ISM (Integrative Systemic Medicine)
Study ID
NCT07637084
Status
Recruiting
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Conditions

  • Chronic Pain
  • Ehlers-Danlos Syndrome, Hypermobile
  • Fatigue Syndrome, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 9, 2026
Start date
May 26, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
25 participants (estimated)

Primary Outcome Measure

Change in chronic pain intensity [ Time Frame: Baseline (T0) to Week 5 (end of PBM treatment cycle) ]

Central Contacts

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