Clinical trial NCT02144532: Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
Official title: Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ehlers-Danlos Syndrome Hypermobility Type
Keywords: Ehlers-Danlos syndrome
hypermobility
Compression garment
pain
isokinetic evaluation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 2 months follow-up
Secondary outcomes:
measure: Level of pain expressed in the shoulders of patients
timeFrame: D0,D28,D56
measure: Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)
timeFrame: D0,D28,D56
measure: Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
timeFrame: D0,D28,D56
measure: Functional independence score measured by Health Assessment Questionnaire (HAQ)
timeFrame: D0,D28,D56
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
Study officials:
affiliation: Centre Médico-Chirurgical de Réadaptation des Massues
name: Emmanuelle CHALEAT-VALAYER, Dr
role: PRINCIPAL_INVESTIGATOR
References: