Clinical trial NCT05449743: Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: spa therapy
phlebology
chronic venous insufficiency
Lead sponsor: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
Sponsor class: OTHER
Collaborators: name: Floralis
name: University Grenoble Alps
name: thermes de NEYRAC
First posted: 2022-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before / after study
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 1.5, 3, 4.5 and 6 months
measure: Assessment of the global quality of life by the EuroQol 5 Dimensions 5 Levels questionnaire (EQ5D-5L).
timeFrame: 3 and 6 months
measure: Physician/Patient perception
timeFrame: 3 and 6 months
measure: Medication consumption
timeFrame: 6 months
measure: Assessment of compression compliance
timeFrame: 3 and 6 months
measure: Evolution of the CEAP (Clinical Etiology Anatomical distribution Pathophysiology) category
timeFrame: 3 and 6 months
measure: Evolution of the general clinical criteria : Body Mass Index (BMI)
timeFrame: 3 and 6 months
measure: Evolution of the general clinical criteria : systolic blood pressure
timeFrame: 3 and 6 months
measure: Evolution of the general clinical criteria : diastolic blood pressure
timeFrame: 3 and 6 months
measure: Evolution of the general clinical criteria : heart rate
timeFrame: 3 and 6 months
measure: 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
timeFrame: 3 and 6 months
measure: Evaluation of the use of care related or not to venous insufficiency 6 months post enrolment
timeFrame: 6 months
measure: Evaluation of compliance with the spa therapy
timeFrame: 3 weeks
measure: Evaluation of the specific quality of life by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
timeFrame: 3 and 6 months
measure: Comparison of the effictiveness of the treatment according to the limitation of the patient's walking (subgroup analysis according to patient mobility)
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Grenoble
country: France
facility: Laboratoire TIMC
Study officials:
References:
citation: Kim Y, Png CYM, Sumpio BJ, DeCarlo CS, Dua A. Defining the human and health care costs of chronic venous insufficiency. Semin Vasc Surg. 2021 Mar;34(1):59-64. doi: 10.1053/j.semvascsurg.2021.02.007. Epub 2021 Feb 3.
citation: Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.
citation: Launois R. Health-related quality-of-life scales specific for chronic venous disorders of the lower limbs. J Vasc Surg Venous Lymphat Disord. 2015 Apr;3(2):219-27.e1-3. doi: 10.1016/j.jvsv.2014.08.005. Epub 2014 Oct 29.
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
citation: Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.