Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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).
- Tiredness [6, 12, 18 and 24 months]
Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ehlers-Danlos syndrome diagnosis confirmed by a medical specialist, according to the new diagnostic criteria of 2017,
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Articular hyperlaxity,
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Have not used compression garments for at least 1 year,
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Without expected body weight change within 6 months,
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Having agreed to participate in the study
Exclusion Criteria:
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Presenting a known allergy to the components of compression garments,
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Presenting acute and unusual pain, not medically controlled,
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Pregnant woman,
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Participating simultaneously with another study or having recently participated in another study for which the exclusion period would not be completed.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Pontier | Clermont-Ferrand | France | 63100 | |
| 2 | Dr Benistan | Garches | France | 92380 | |
| 3 | Dr Michot | Paris | France | 75015 | |
| 4 | Dr Enjalbert | Perpignan | France | ||
| 5 | SLB Pharma | Rennes | France | 35000 |
Sponsors and Collaborators
- Cerecare
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEDCARE