Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes

Cerecare76 enrolled

Overview

EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility. The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient. The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect. The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eds, Unspecified Type

Interventions

Cerecare compression garmentsDEVICE

all Cerecare compression garments

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ehlers-Danlos syndrome diagnosis confirmed by a medical specialist, according to the new diagnostic criteria of 2017, * Articular hyperlaxity, * Have not used compression garments for at least 1 year, * Without expected body weight change within 6 months, * Having agreed to participate in the study Exclusion Criteria: * Presenting a known allergy to the components of compression garments, * Presenting acute and unusual pain, not medically controlled, * Pregnant woman, * Participating simultaneously with another study or having recently participated in another study for which the exclusion period would not be completed.

Locations (5)

Dr Pontier

Clermont-Ferrand, France

Dr Benistan

Garches, France

Dr Michot

Paris, France

Dr Enjalbert

Perpignan, France

SLB Pharma

Rennes, France

Outcomes

Primary Outcomes

Joint pain assessment

Assessment of the most painful joint by an VAS (Visual Analog Scale) \[0-100mm\]. The most painful joint at 0 months (= before use Compression Garments) will be choose as the primary outcome measure. The primary outcome measure will be done at 6 months.

Time frame: 6 months

Secondary Outcomes

Joint pain assessment

Assessment of joint pain by an VAS (Visual Analog Scale) \[0-100mm\]: shoulder, elbow, wrist, finger, hip, knee, ankle.