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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with EDS hypermobility type | Experimental | Patients with EDS hypermobility type wearing compression garment then compression garment removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short-sleeved vest CICATREX SED®) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Power (in watts) of the external rotators of the shoulder of the dominant arm measured by concentric isokinetic evaluation at a constant angular velocity of 180 °/s | The evaluations will be conducted 3 times:
| 2 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain expressed in the shoulders of patients | Evaluation of the level of pain each month by the physician investigator on Visual Analogue Scale :
| D0,D28,D56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuelle CHALEAT-VALAYER, MD | Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française | Lyon | 69322 | France |
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| ID | Term |
|---|---|
| C536196 | Ehlers-Danlos syndrome type 3 |
| D004535 | Ehlers-Danlos Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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|
| Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale) | The score of quality of life is measured by self-administered questionnaire (SF-36 scale) at each follow-up visit:
| D0,D28,D56 |
| Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) | The score of satisfaction is measured by self-administered questionnaire (QUEST) at each follow-up visit:
| D0,D28,D56 |
| Functional independence score measured by Health Assessment Questionnaire (HAQ) | The score of functional independence is measured by self-administered questionnaire (HAQ) at each follow-up visit:
| D0,D28,D56 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |