Chronic Venous Insufficiency and Balneotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: Phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with C4-C5 of severity classification). The multicenter randomized controlled trial (RCT) Thermes & Veines that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. The French National Academy of Medicine encourages the re-use of data of published RCT when available. In this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. The Control group consists of the 197 patients which were allocated to the Control group of the Thermes & Veines. All patients enrolled in the current study benefit of 18-days of spa treatment with Mineral Water of Royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.

Detailed Description
-----------------
Chronic Vascular Disease (CVD) related quality of life and symptoms, as well as skin trophic changes from baseline are assessed at 6 months. Variations from baseline are compared in Control and Spa treatment groups. The indirect comparison methodology is based on the reuse of individual data from a control group and adjustment after calculating the propensity score.

Official Title
-----------------
Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency

Conditions
-----------------
Venous Insufficiency (Chronic)(Peripheral)

Intervention / Treatment
-----------------
* Procedure: SPA THERAPY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary or post-thrombotic CVD with confirmed diagnosis by by duplex ultrasound examination (last available exam); With CVI classified as C4a, C4b, or C5) Available for balneotherapy program within the 2 next months With health insurance affiliation. Exclusion Criteria: Active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index < 0.70). Walking difficulty Neurologic diseases of the lower limbs Presenting or likely to present a contraindication to thermal treatments, with planned surgery; Having already benefited from a thermal treatment whatever the indication during the last 6 months Chronic infectious disease, cancer, heart, kidney or liver failure; Pregnant, breastfeeding women or women planning a pregnancy within the year; Persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent; Patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up; Living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site; Already included in a clinical trial or in the exclusion period of a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SPA THERAPY PROGRAM<br>3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency | Procedure: SPA THERAPY<br>* Balneotherapy program Four balneotherapy sessions per day, 6 days a week during 3 weeks The balneotherapy sessions included: 10- minute walking session in a specially designed pool with tracks in semideep (80 cm) cool (30°C) water (training of muscle pump function under water compression); 20-minute whirlpool bath session with automatic air or submarine bath if hypodermis (aimed at relaxation and mobilization of the superficial skin volume flow); followed by a 10-minute hydrojet bath (2 sessions) with customized underwater strong massaging jets (mobilization and softening of the sclerotic subcutaneous tissues); Fresh thermal water compresses at 24°C. The cool temperature of the compresses also has an analgesic and decongestant effect. This treatment is carried out last and is followed by a rest for a total duration of 60 minutes<br>* Other names: BALNEOTHERAPY THERAPEUTIC ORIENTATION PHLEBOLOGY;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in CIVIQ-2 score at 6 months | The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency on patients' lives. CIVIQ-2 or CIVIQ-20 is a self-administered questionnaire that consists in 20 questions of the CIVIQ result in a global score. All questions have a 5-point response category, with higher scores reflecting more severe impairment. The CIVIQ-20 score ranges from 20 (minimal impact) to 100 (maximal impact). | Baseline (D1) and final (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Quality of Life at 6 months | Quality of life is measured using the generic EUROQOL (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state). | Baseline (D1) and final (6 months) | 
| Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months | Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS). | Baseline (D1) and final (6 months) | 
| Frequency of adverse events throughout the study | Adverse events are described using MedDRA and each event frequency is calculated. | From inclusion to the final visit at 6 months] | 
| Participants' satisfaction with the spa therapy program at the end of the program and at 6 months | Opinion of the patient is measured using a 5-point Likert scale ranging from 1 (not at all satisfied) to 5 (very satisfied) | 20 days and 6 months | 
| Medical-economic impact of the spa therapy program at 6 months | EQ-5D-3L score at 6 months and frequency of adverse events related to chronic venous insufficiency. scores ranges from -0.541 (higher impact of health on quality of life) to 0.982 (lower impact of health on quality of life) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spa therapy,, Balneotherapy, Chronic venous insufficiency, CVI, CVD