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| Name | Class |
|---|---|
| TOWN HALL OF ROYAT | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPA THERAPY PROGRAM | 3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPA THERAPY | Procedure | Balneotherapy program Four balneotherapy sessions per day, 6 days a week during 3 weeks The balneotherapy sessions included:
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| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients meeting the eligibility criteria and living, or with possible accomodation, at less than 30 minutes from Royat (Auvergne, France)
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| Name | Affiliation | Role |
|---|---|---|
| Geoffroy COUCHET, PD | Private Practitioner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thermes de Royat | Royat | Auvergne | 63130 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24135621 | Background | 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. |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |