NCT05449743已完成不适用
Evaluation of the Effectiveness of a Phlebology-oriented Spa Treatment on the Quality of Life of Patients Suffering from Chronic Venous Insufficiency of the Lower Limbs, 6-month After the Spa Treatment
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To evaluate the effectiveness of a complete phlebology-oriented spa therapy on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs
研究概览
简要总结
Evaluation of the effectiveness of a phlebology-oriented spa therapy at 6 months on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs
详细描述
NEYRAC is a:
- prospective, before/after, cohort follow-up study with repeated measurements
- monocentric study with the dispensation of a 3-week phlebology-oriented spa therapy in Neyrac-les-Bains
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Patient with chronic venous insufficiency of the lower limbs (CEAP category C4a, C4b and C4c)
- •Patient presenting an indication for a phlebology-oriented spa treatment as the primary orientation. Patients with a dermatological or rheumatological pathology can benefit from a dual orientation spa treatment with a main phlebology orientation
- •Patient affiliated to the social security system or such a system
- •Available for an 18-day spa treatment and a 6-month follow-up
- •For women of childbearing age: effective contraception
- •Patient close to a study investigator (excluding teleconsultation) If not patient with access to the necessary equipment to perform a teleconsultation (smartphone, tablet or computer with an internet connection + taking and sending photos of the lower limbs)
- •Non inclusion criteria:
- •Venous surgery or venous interventional therapy within 3 months prior to inclusion or scheduled within the next 3 months
- •History of venous ulcer
- •Contraindication to spa therapy (immune deficiency, evolving cardiopathy neoplasia, infection, pulmonary tuberculosis, severe renal insufficiency, alcoholic cirrhosis, advanced senility and severe mental disorders)
- •Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.)
- •Persons suffering from venous insufficiency of the varicose vein type (category CEAP C2) or edema alone (category CEAP C3) or open or healed ulcers (CEAP category C5 and C6)
- •Patient who has already undergone a phlebology-oriented spa treatment within the current thermal season
- •Subject already included in an interventional clinical research protocol
- •Persons referred to in articles L1121-5 to L1121-8 of the "Code de la Santé Publique" (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
排除标准
- 未提供
结局指标
主要结局
To evaluate the effectiveness of a complete phlebology-oriented spa therapy on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs
时间窗: 6 months
Comparison of the mean scores of the Chronic Venous Insufficiency specific Quality of life questionnaire (CIVIQ20) at baseline and at 6 months. The 20-item questionnaire, which provides a global index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). Items on the CIVIQ-20 scale were scored from 1 to 5 which means a total score from 20 to 100. A higher score means a worse outcome.
次要结局
- Comparison of Visual Analog Scales (VAS) for pain at enrolment and 1.5, 3, 4.5 and 6 months after enrolment (post-cure) to quantitatively assess the improvement of patients' pain before/after treatment(1.5, 3, 4.5 and 6 months)
- Medication consumption(6 months)
- Assessment of compression compliance(3 and 6 months)
- Evolution of the CEAP (Clinical Etiology Anatomical distribution Pathophysiology) category(3 and 6 months)
- Assessment of the global quality of life by the EuroQol 5 Dimensions 5 Levels questionnaire (EQ5D-5L).(3 and 6 months)
- Physician/Patient perception(3 and 6 months)
- Evolution of the general clinical criteria : systolic blood pressure(3 and 6 months)
- Evolution of the general clinical criteria : diastolic blood pressure(3 and 6 months)
- Evaluation of the Rutherford score at enrolment and at 3 months and at 6 months after enrolment to estimate the clinical severity of venous insufficiency(3 and 6 months)
- Comparison of the effictiveness of the treatment according to the limitation of the patient's walking (subgroup analysis according to patient mobility)(6 months)
- Evolution of the general clinical criteria : Body Mass Index (BMI)(3 and 6 months)
- Evaluation of compliance with the spa therapy(3 weeks)
- Evolution of the general clinical criteria : heart rate(3 and 6 months)
- Evaluation of the use of care related or not to venous insufficiency 6 months post enrolment(6 months)
- Evaluation of the specific quality of life by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire(3 and 6 months)
研究者
研究点 (4)
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