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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0) to Week 5 (end of PBM treatment cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 5 to Week 10 (5 weeks post-treatment follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of PBM therapy | Frequency and nature of local adverse events (redness, discomfort, transient pain aggravation) recorded at each session by the investigator. | Each session, from Week 1 to Week 5 (sessions 1 to 10) |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with confirmed hypermobile Ehlers-Danlos Syndrome (hEDS), diagnosed according to the 2017 International Consortium criteria, presenting with chronic pain (≥ 3 months, VAS ≥ 4/10) and/or fatigue, followed in private outpatient practice at Centre Médical ISM, Boulogne-Billancourt, France. Patients are recruited consecutively among those already receiving photobiomodulation therapy as part of their routine care. No healthy volunteers are included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilian Lessedjina, M.D. | Contact | +337-82-83-40-83 | dr.llessedjina@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical ISM | Recruiting | Boulogne-Billancourt | Île-de-France Region | 92100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20140961 | Background | Castori M, Camerota F, Celletti C, Danese C, Santilli V, Saraceni VM, Grammatico P. Natural history and manifestations of the hypermobility type Ehlers-Danlos syndrome: a pilot study on 21 patients. Am J Med Genet A. 2010 Mar;152A(3):556-64. doi: 10.1002/ajmg.a.33231. | |
| 28306229 | Background | Malfait F, Francomano C, Byers P, Belmont J, Berglund B, Black J, Bloom L, Bowen JM, Brady AF, Burrows NP, Castori M, Cohen H, Colombi M, Demirdas S, De Backer J, De Paepe A, Fournel-Gigleux S, Frank M, Ghali N, Giunta C, Grahame R, Hakim A, Jeunemaitre X, Johnson D, Juul-Kristensen B, Kapferer-Seebacher I, Kazkaz H, Kosho T, Lavallee ME, Levy H, Mendoza-Londono R, Pepin M, Pope FM, Reinstein E, Robert L, Rohrbach M, Sanders L, Sobey GJ, Van Damme T, Vandersteen A, van Mourik C, Voermans N, Wheeldon N, Zschocke J, Tinkle B. The 2017 international classification of the Ehlers-Danlos syndromes. Am J Med Genet C Semin Med Genet. 2017 Mar;175(1):8-26. doi: 10.1002/ajmg.c.31552. |
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| D059350 | Chronic Pain |
| D015673 | Fatigue Syndrome, Chronic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| 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. | 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). | Baseline (T0), Week 5 (T5), and Week 10 (T10) |
| 36110957 | Background | Robijns J, Nair RG, Lodewijckx J, Arany P, Barasch A, Bjordal JM, Bossi P, Chilles A, Corby PM, Epstein JB, Elad S, Fekrazad R, Fregnani ER, Genot MT, Ibarra AMC, Hamblin MR, Heiskanen V, Hu K, Klastersky J, Lalla R, Latifian S, Maiya A, Mebis J, Migliorati CA, Milstein DMJ, Murphy B, Raber-Durlacher JE, Roseboom HJ, Sonis S, Treister N, Zadik Y, Bensadoun RJ. Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. 2022 Aug 30;12:927685. doi: 10.3389/fonc.2022.927685. eCollection 2022. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |