Clinical Trial: Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome

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 cou

    Detailed Summary:
    Sponsor: Hospices Civils de Lyon

    Current Primary Outcome: 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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)
    • 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)
    • 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)
    • 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)


    Original Secondary Outcome: Same as current

    Information By: Hospices Civils de Lyon

    Dates:
    Date Received: May 7, 2014
    Date Started: May 2014
    Date Completion: May 2017
    Last Updated: July 8, 2014
    Last Verified: July 2014