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

Ehlers-Danlos Syndrome Hypermobility Type Clinical Trial

— VETCOSED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144532
• Other study ID #: 2012-755
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2014
• Last updated: August 22, 2017
• Start date: May 2014
• Est. completion date: January 2018

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: Emmanuelle CHALEAT-VALAYER, Dr
• Phone: 472.38.46.28
• Email: chaleat-valayer.e[@]cmcr-massues.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Ehlers-Danlos Syndrome Hypermobility Type
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
France	Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 months follow-up
Secondary	Level of pain expressed in the shoulders of patients	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)	D0,D28,D56
Secondary	Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)	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)	D0,D28,D56
Secondary	Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)	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)	D0,D28,D56
Secondary	Functional independence score measured by Health Assessment Questionnaire (HAQ)	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)	D0,D28,D56