- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02144532
Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome (VETCOSED)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emmanuelle CHALEAT-VALAYER, Dr
- Phone Number: +33 472.38.46.28
- Email: chaleat-valayer.e@cmcr-massues.com
Study Contact Backup
- Name: Amélie ZELMAR
- Phone Number: +33 472.11.51.15
- Email: amelie.zelmar@chu-lyon.fr
Study Locations
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Lyon, France, 69322
- Recruiting
- Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
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Contact:
- Emmanuelle CHALEAT-VALAYER, Dr
- Phone Number: +33 472.38.46.28
- Email: chaleat-valayer.e@cmcr-massues.com
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Contact:
- Amélie ZELMAR
- Phone Number: +33 472.11.51.15
- Email: amelie.zelmar@chu-lyon.fr
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Principal Investigator:
- Emmanuelle CHALEAT-VALAYER, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- hyperalgic episode in progress
- unstable cardiac disease
- previous history of shoulder surgery
- severe skin lesions,
- pregnancy in progress
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with EDS hypermobility type
Patients with EDS hypermobility type wearing compression garment then compression garment removal
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 2 months follow-up
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The evaluations will be conducted 3 times:
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2 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of pain expressed in the shoulders of patients
Time Frame: D0,D28,D56
|
Evaluation of the level of pain each month by the physician investigator on Visual Analogue Scale :
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D0,D28,D56
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Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)
Time Frame: D0,D28,D56
|
The score of quality of life is measured by self-administered questionnaire (SF-36 scale) at each follow-up visit:
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D0,D28,D56
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Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Time Frame: D0,D28,D56
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The score of satisfaction is measured by self-administered questionnaire (QUEST) at each follow-up visit:
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D0,D28,D56
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Functional independence score measured by Health Assessment Questionnaire (HAQ)
Time Frame: D0,D28,D56
|
The score of functional independence is measured by self-administered questionnaire (HAQ) at each follow-up visit:
|
D0,D28,D56
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emmanuelle CHALEAT-VALAYER, Dr, Centre Médico-Chirurgical de Réadaptation des Massues
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Hemostatic Disorders
- Skin Diseases, Genetic
- Skin Abnormalities
- Collagen Diseases
- Syndrome
- Ehlers-Danlos Syndrome
Other Study ID Numbers
- 2012-755
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University Hospital, CaenCompletedEhlers-Danlos Syndrome Hypermobility Type (hEDS)France
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Istituto Ortopedico RizzoliRecruitingCollagen Diseases | Joint Hypermobility | Hypermobility Syndrome | Laxity of Ligament | Danlos Disease, EhlersItaly
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University Hospital, LinkoepingLinkoeping University; Medical Research Council of Southeast Sweden; Länssjukhuset...CompletedHypermobile Ehlers-Danlos Syndrome | Hypermobility SyndromeSweden
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University GhentTerminatedHypermobile Ehlers-Danlos Syndrome | Hypermobility Syndrome | Multidirectional Subluxation of ShoulderBelgium
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