Informations générales (source: ClinicalTrials.gov)
Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome (VETCOSED)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
mai 2014
janvier 2018
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| IFSI CROIX-ROUGE FRANCAISE | Emmanuelle CHALEAT-VALAYER, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- hyperalgic episode in progress
- unstable cardiac disease
- previous history of shoulder surgery
- severe skin lesions,
- pregnancy in progress