Ehlers-Danlos Syndrome Hypermobility Type Clinical Trial
Official title:
Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04310644 -
Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry
|