Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 26, 2020

Interventions

  • Device: Cerecare compression garments
    • all Cerecare compression garments

Clinical Trial Outcome Measures

Primary Measures

  • Joint pain assessment
    • Time Frame: 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 Measures

  • Joint pain assessment
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 6, 12, 18 and 24 months
    • Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].
  • Patient’s quality of life
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 6, 12, 18 and 24 months
    • By questioning the patient, estimate the number of hours of compression garments daily use.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cerecare
  • Provider of Information About this Clinical Study
    • Sponsor

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