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NCT Number: NCT07637084

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

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.

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Key information

Conditions

Ehlers-Danlos Syndrome, Hypermobile Cardiovascular Diseases Chronic Disease Chronic Pain Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Disease Attributes Ehlers-Danlos Syndrome Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Médical ISM

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location status: Recruiting

Location contact

Lilian Lessedjina, M.D.

CONTACT

[email protected]

+337-82-83-40-83

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in chronic pain intensity

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

    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.

Secondary outcomes

  1. Durability of pain relief

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

    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

  2. Change in multidimensional fatigue

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

    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.

  3. Change in health-related quality of life

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

    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).

Other outcomes

  1. Tolerability of PBM therapy

    Time frame: Each session, from Week 1 to Week 5 (sessions 1 to 10)

    Frequency and nature of local adverse events (redness, discomfort, transient pain aggravation) recorded at each session by the investigator.

Study contacts

Contact information is provided by the study sponsor or research team.

Lilian Lessedjina, M.D.

CONTACT

[email protected]

+337-82-83-40-83

Sponsors and collaborators

Lead sponsor

Centre Medical ISM (Integrative Systemic Medicine)

Other

Registry information

Official study 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

Acronym: PBM-SEDh-01

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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