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

Centre Medical ISM (Integrative Systemic Medicine)25 enrolled

Overview

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.

Background: Hypermobile Ehlers-Danlos Syndrome (hEDS) is the most common form of EDS (80-90% of cases), diagnosed according to the 2017 International Consortium criteria. Chronic pain and fatigue are the two most disabling symptoms. No randomized controlled trial has evaluated the effect of MLS® class IV laser photobiomodulation in hEDS to date. Intervention: Photobiomodulation using ASAlaser M-Hi device (MLS® technology: synchronized 808nm continuous + 905nm pulsed emissions, CE MDR class IV). Progressive fluence: 4 J/cm² (sessions 1-2), 6 J/cm² (sessions 3-6), 8 J/cm² (sessions 7-10). Maximum 3-4 zones per session. Treatment areas individualized based on pain mapping at baseline. Design: Single-center prospective observational pilot study in private practice. No randomization, no control group, no modification of ongoing treatment. Statistical analysis: Wilcoxon signed-rank tests (paired, non-parametric), descriptive statistics. Exploratory pilot - no formal power calculation. Target sample size: 20-25 patients.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ehlers-Danlos Syndrome, Hypermobile

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in chronic pain intensity

Change in pain intensity measured by the Visual Analogue Scale (VAS, 0-10), representing average pain over the preceding week. A decrease of ≥ 1.5 points is considered clinically meaningful.

Time frame: Baseline (T0) to Week 5 (end of PBM treatment cycle)

Secondary Outcomes

Durability of pain relief

Change in pain intensity assessed by the Visual Analogue Scale (VAS, 0-10, where 0 = no pain and 10 = worst pain imaginable; lower scores indicate less pain), between end of treatment (Week 5) and follow-up (Week 10), to assess persistence of the analgesic effect after PBM cessation

Time frame: Week 5 to Week 10 (5 weeks post-treatment follow-up)

Change in multidimensional fatigue

Change in fatigue assessed by the Multidimensional Fatigue Inventory (MFI-20), comprising 20 items across 5 subscales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue. Total score ranges from 20 to 100.

Time frame: Baseline (T0), Week 5 (T5), and Week 10 (T10)

Change in health-related quality of life

Change in quality of life assessed by the EQ-5D-5L questionnaire (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and the EQ Visual Analogue Scale (EQ-VAS, 0-100).