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

NCT ID: NCT02144532

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-23
• Study Completion Date: 2018-04-05

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

Conditions

Ehlers-Danlos Syndrome Hypermobility Type

Keywords

Ehlers-Danlos syndrome; hypermobility; Compression garment; pain; isokinetic evaluation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients with EDS hypermobility type

Patients with EDS hypermobility type wearing compression garment then compression garment removal

Group Type: EXPERIMENTAL

short-sleeved vest CICATREX SED®)

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle CHALEAT-VALAYER, MD

Role: PRINCIPAL_INVESTIGATOR

Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues

Locations

Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française

Lyon, , France

Countries

France

Other Identifiers

2012-755

Identifier Type: -

Identifier Source: org_study_id