Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome (VETCOSED)
Primary Purpose
Ehlers-Danlos Syndrome Hypermobility Type
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
short-sleeved vest CICATREX SED®)
Sponsored by
About this trial
This is an interventional supportive care trial for Ehlers-Danlos Syndrome Hypermobility Type focused on measuring Ehlers-Danlos syndrome, hypermobility, Compression garment, pain, isokinetic evaluation
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
Sites / Locations
- Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge françaiseRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with EDS hypermobility type
Arm Description
Patients with EDS hypermobility type wearing compression garment then compression garment removal
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02144532
Brief Title
Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
Acronym
VETCOSED
Official Title
Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ehlers-Danlos Syndrome Hypermobility Type
Keywords
Ehlers-Danlos syndrome, hypermobility, Compression garment, pain, isokinetic evaluation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with EDS hypermobility type
Arm Type
Experimental
Arm Description
Patients with EDS hypermobility type wearing compression garment then compression garment removal
Intervention Type
Device
Intervention Name(s)
short-sleeved vest CICATREX SED®)
Intervention Description
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 Measure Information:
Title
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
Description
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.
Time Frame
2 months follow-up
Secondary Outcome Measure Information:
Title
Level of pain expressed in the shoulders of patients
Description
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)
Time Frame
D0,D28,D56
Title
Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)
Description
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)
Time Frame
D0,D28,D56
Title
Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Description
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)
Time Frame
D0,D28,D56
Title
Functional independence score measured by Health Assessment Questionnaire (HAQ)
Description
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)
Time Frame
D0,D28,D56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle CHALEAT-VALAYER, Dr
Phone
472.38.46.28
Ext
+33
Email
chaleat-valayer.e@cmcr-massues.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie ZELMAR
Phone
472.11.51.15
Ext
+33
Email
amelie.zelmar@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle CHALEAT-VALAYER, Dr
Organizational Affiliation
Centre Médico-Chirurgical de Réadaptation des Massues
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
City
Lyon
ZIP/Postal Code
69322
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle CHALEAT-VALAYER, Dr
Phone
472.38.46.28
Ext
+33
Email
chaleat-valayer.e@cmcr-massues.com
First Name & Middle Initial & Last Name & Degree
Amélie ZELMAR
Phone
472.11.51.15
Ext
+33
Email
amelie.zelmar@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle CHALEAT-VALAYER, Dr
12. IPD Sharing Statement
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Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
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