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

Civil Hospices of Lyon

Status

Completed

Conditions

Ehlers-Danlos Syndrome Hypermobility Type

Treatments

Device: short-sleeved vest CICATREX SED®)

Study type

Interventional

Funder types

Other

Identifiers

NCT02144532

2012-755

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ehlers-Danlos syndrome hypermobility type confirmed the diagnosis of a geneticist
with an instability of one or both shoulders, painful or considered invalidating by the patient (recurrent dislocation or subluxation : at least once / month or at least 12 times / year)
having a joint hypermobility syndrome (abnormal mobility and in a non-physiological axis), with a Beighton score of greater than or equal to 5 of 9
age greater than or equal to 18 years
size greater than or equal to 1 m 40
sufficient understanding of the French language in order to respond to self-report questionnaires

Exclusion criteria