Eds, Unspecified Type
Conditions
Brief summary
EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility. The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient. The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect. The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.
Interventions
DEVICECerecare compression garments
all Cerecare compression garments
Sponsors
Cerecare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ehlers-Danlos syndrome diagnosis confirmed by a medical specialist, according to the new diagnostic criteria of 2017, * Articular hyperlaxity, * Have not used compression garments for at least 1 year, * Without expected body weight change within 6 months, * Having agreed to participate in the study
Exclusion criteria
* Presenting a known allergy to the components of compression garments, * Presenting acute and unusual pain, not medically controlled, * Pregnant woman, * Participating simultaneously with another study or having recently participated in another study for which the exclusion period would not be completed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint pain assessment | 6 months | Assessment of the most painful joint by an VAS (Visual Analog Scale) \[0-100mm\]. The most painful joint at 0 months (= before use Compression Garments) will be choose as the primary outcome measure. The primary outcome measure will be done at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily monitoring of joint instability | 6, 12, 18 and 24 months | Daily monitoring of joint instability as sprain, dislocation and subluxation (shoulder, elbow, wrist, finger, hip, knee, ankle). |
| Neuropathic pain assessment | 6, 12, 18 and 24 months | Assessment of neuropathic pain by the PAIN Detect questionnaire. The PAIN Detect questionnaire contains: * 3 numerical scales (NS) \[0-10\], * 7 items with categorical response (never, hardly noticed, slightly, moderately, strongly, very strongly). |
| Proprioception disorders | 6, 12, 18 and 24 months | Assessment of proprioception disorders by the Berg Balance Scale (BBS) \[0-56\]. The BBS contains 14 items; each item is scored from 0 to 4. |
| Functional independence assessment | 6, 12, 18 and 24 months | Assessment of functional independence by the Functional Independence Measure (FIM) \[18-126\]. The FIM contains 18 items; each item is scored from 1 (total assistance) to 7 (complete independence). |
| Joint pain assessment | 6, 12, 18 and 24 months | Assessment of joint pain by an VAS (Visual Analog Scale) \[0-100mm\]: shoulder, elbow, wrist, finger, hip, knee, ankle. |
| Patient's quality of life | 6, 12, 18 and 24 months | Assessment of Life quality by the SF-12 questionnaire (Short Form questionnaire on quality of life with 12 items). |
| Tolerance: incidence of Treatment-Emergent Adverse Events | 6, 12, 18 and 24 months | By questioning the patient and by a medical exam, evaluation of adverse effect due to compression garments (Yes/ No): itch, edema, blister, redness, dermal ulceration. |
| Compliance | 6, 12, 18 and 24 months | By questioning the patient, estimate the number of hours of compression garments daily use. |
| Tiredness | 6, 12, 18 and 24 months | Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) \[1-7\]. |
Countries
France
Outcome results
None listed