Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cerecare
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Joint pain assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Joint pain assessment
时间窗: 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.
次要结局
- Daily monitoring of joint instability(6, 12, 18 and 24 months)
- Neuropathic pain assessment(6, 12, 18 and 24 months)
- Proprioception disorders(6, 12, 18 and 24 months)
- Tiredness(6, 12, 18 and 24 months)
- Joint pain assessment(6, 12, 18 and 24 months)
- Patient's quality of life(6, 12, 18 and 24 months)
- Tolerance: incidence of Treatment-Emergent Adverse Events(6, 12, 18 and 24 months)
- Functional independence assessment(6, 12, 18 and 24 months)
- Compliance(6, 12, 18 and 24 months)