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

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ClinicalTrials.gov Identifier: NCT02144532
Recruitment Status : Recruiting
First Posted : May 22, 2014
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome Hypermobility Type Device: short-sleeved vest CICATREX SED®) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
Study Start Date : May 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with EDS hypermobility type
Patients with EDS hypermobility type wearing compression garment then compression garment removal
Device: short-sleeved vest CICATREX SED®)
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).




Primary Outcome Measures :
  1. 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 ]

    The evaluations will be conducted 3 times:

    • at the inclusion (D0)
    • at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
    • at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56) For each measurement, evaluations will be made with then without the compression garment.


Secondary Outcome Measures :
  1. 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 :

    • at the inclusion (D0)
    • at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
    • at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)

  2. 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:

    • at the inclusion (D0)
    • at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
    • at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)

  3. Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) [ Time Frame: D0,D28,D56 ]

    The score of satisfaction is measured by self-administered questionnaire (QUEST) at each follow-up visit:

    • at the inclusion (D0)
    • at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
    • at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)

  4. 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:

    • at the inclusion (D0)
    • at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
    • at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144532


Contacts
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Contact: Emmanuelle CHALEAT-VALAYER, Dr 472.38.46.28 ext +33 chaleat-valayer.e@cmcr-massues.com
Contact: Amélie ZELMAR 472.11.51.15 ext +33 amelie.zelmar@chu-lyon.fr

Locations
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France
Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française Recruiting
Lyon, France, 69322
Contact: Emmanuelle CHALEAT-VALAYER, Dr    472.38.46.28 ext +33    chaleat-valayer.e@cmcr-massues.com   
Contact: Amélie ZELMAR    472.11.51.15 ext +33    amelie.zelmar@chu-lyon.fr   
Principal Investigator: Emmanuelle CHALEAT-VALAYER, Dr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Emmanuelle CHALEAT-VALAYER, Dr Centre Médico-Chirurgical de Réadaptation des Massues

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02144532     History of Changes
Other Study ID Numbers: 2012-755
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
Ehlers-Danlos syndrome
hypermobility
Compression garment
pain
isokinetic evaluation

Additional relevant MeSH terms:
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Syndrome
Ehlers-Danlos Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases