Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome (PBM-SEDh-01) (PBM-SEDh-01)
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
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Lilian Lessedjina, M.D.
- Telefonnummer: +337-82-83-40-83
- E-post: dr.llessedjina@gmail.com
Studiesteder
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Île-de-France Region
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Boulogne-Billancourt, Île-de-France Region, Frankrike, 92100
- Rekruttering
- Centre Médical ISM
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Ta kontakt med:
- Lilian Lessedjina, M.D.
- Telefonnummer: +337-82-83-40-83
- E-post: dr.llessedjina@gmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in chronic pain intensity
Tidsramme: Baseline (T0) to Week 5 (end of PBM treatment cycle)
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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.
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Baseline (T0) to Week 5 (end of PBM treatment cycle)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in multidimensional fatigue
Tidsramme: Baseline (T0), Week 5 (T5), and Week 10 (T10)
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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)
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Change in health-related quality of life
Tidsramme: Baseline (T0), Week 5 (T5), and Week 10 (T10)
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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).
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Baseline (T0), Week 5 (T5), and Week 10 (T10)
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Durability of pain relief
Tidsramme: Week 5 to Week 10 (5 weeks post-treatment follow-up)
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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
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Week 5 to Week 10 (5 weeks post-treatment follow-up)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tolerability of PBM therapy
Tidsramme: Each session, from Week 1 to Week 5 (sessions 1 to 10)
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Frequency and nature of local adverse events (redness, discomfort, transient pain aggravation) recorded at each session by the investigator.
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Each session, from Week 1 to Week 5 (sessions 1 to 10)
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevroinflammatoriske sykdommer
- Smerte
- Nevrologiske manifestasjoner
- Muskel- og skjelettsykdommer
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Muskelsykdommer
- Patologiske prosesser
- Encefalomyelitt
- Nevromuskulære sykdommer
- Kronisk sykdom
- Sykdomsattributter
- Genetiske sykdommer, medfødte
- Bindevevssykdommer
- Hematologiske sykdommer
- Hudsykdommer
- Medfødte abnormiteter
- Hemostatiske lidelser
- Hemoragiske lidelser
- Hudsykdommer, genetisk
- Hudavvik
- Kollagen sykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Patologiske tilstander, tegn og symptomer
- Hud- og bindevevssykdommer
- Tegn og symptomer
- Hemic og lymfatiske sykdommer
- Tretthetssyndrom, kronisk
- Kronisk smerte
- Utmattelse
- Ehlers-Danlos syndrom
Andre studie-ID-numre
- PBM-SEDh-01
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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