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Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome

NCT02144532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-19

No results posted yet for this study

Summary

The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the connective tissue. This syndrome has different forms. Hypermobility type is the most common. It is characterized by generalized joint hypermobility, associated with a chronic pain syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived and the most crippling.

Faced with insufficient effect of drug treatment, other alternatives have been proposed to relieve these patients. Compression garments have been developed. They appear as medical devices targeted specifically for patients with hypermobility EDS type: in the symptomatic treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle globulization, and in the functional improvement.

The VETCOSED study is a quasi-experimental study of type "Before / After", monocentric, open. The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which they do not carry this garment.

The main objective is to demonstrate the effectiveness of compression garments in the EDS hypermobility type, especially in terms of symptomatic improvement joint pain.

The main outcomes expected of this study are:

* an improvement of the power and the peaks of couple of muscles rotators of shoulders.
* a decrease of the pains and the defects of articular stability of the shoulder
* an improvement of the quality of life and the functional independence of these patients

Conditions

  • Ehlers-Danlos Syndrome Hypermobility Type

Interventions

DEVICE

short-sleeved vest CICATREX SED®)

Each patient wears a compression custom-made garment (short-sleeved vest CICATREX SED®) according to the medical prescription during the first 4 weeks (BEFORE phase). Then each patient should not wear the compression garment for the next 4 weeks (AFTER phase).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Emmanuelle CHALEAT-VALAYER, MD · Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-23
Primary Completion
2018-04-05
Completion
2018-04-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144532 on ClinicalTrials.gov