Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)

Le Syndicat Intercommunal pour le Thermalisme et l'Environnement

Status: Completed

Conditions: Chronic Venous Insufficiency

Treatments: Other: Spa therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05449743

2021-A00545-36

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

patient treated with a phlebology-oriented spa therapy

Experimental group

Description:

Thermal treatments among the following: pool, Kneipp pool, high pressure shower under immersion in a swimming pool, general jet shower, cataplasm in multiple local application, compress, massage under water or with thermal derivatives, walking corridor

Treatment:

Other: Spa therapy