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

NCT07637084 | Recruiting

• 1 other identifier: PBM-SEDh-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

photobiomodulation; laser therapy; MLS laser; Ehlers-Danlos syndrome; chronic pain; fatigue; quality of life; observational study; pilot study

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Durability of pain relief

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

• Change in multidimensional fatigue

  Baseline (T0), Week 5 (T5), and Week 10 (T10)

• Change in health-related quality of life

  Baseline (T0), Week 5 (T5), and Week 10 (T10)

Other Outcomes (1)

• Tolerability of PBM therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Suspicious or malignant skin lesion on areas to be treated
• Non-modifiable photosensitizing treatment
• Pregnancy or breastfeeding
• Photosensitive epilepsy
• Simultaneous participation in another research protocol

Sponsors & Collaborators

• Centre Medical ISM (Integrative Systemic Medicine): lead

Study Sites (1)

Centre Médical ISM

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

RECRUITING

Related Publications (3)

• 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.

  PMID: 20140961 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.

  PMID: 28306229 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.

  PMID: 36110957 BACKGROUND

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Chronic Pain; Fatigue Syndrome, Chronic; Fatigue

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lilian Lessedjina, M.D.

CONTACT

+337-82-83-40-83; dr.llessedjina@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)