Chronic Venous Insufficiency and Balneotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: CONTROL Standard of care for advanced chronic venous insufficiency |
|
| Experimental: SPA THERAPY PROGRAM 3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency |
Procedure: SPA THERAPY
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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Changes from baseline in CIVIQ-2 score at 6 months [Baseline (D1) and final (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).
Secondary Outcome Measures
- Changes from baseline in Quality of Life at 6 months [Baseline (D1) and final (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).
- Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months [Baseline (D1) and final (6 months)]
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).
- Frequency of adverse events throughout the study [From inclusion to the final visit at 6 months]]
Adverse events are described using MedDRA and each event frequency is calculated.
- Participants' satisfaction with the spa therapy program at the end of the program and at 6 months [20 days and 6 months]
Opinion of the patient is measured using a 5-point Likert scale
- Medical-economic impact of the spa therapy program at 6 months [6 months]
EQ-5D-3L score at 6 months and frequency of adverse events related to chronic venous insufficiency
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary or post-thrombotic CVD with confirmed diagnosis by by duplex ultrasound examination (last available exam);
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With CVI classified as C4a, C4b, or C5)
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Available for balneotherapy program within the 2 next months
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With health insurance affiliation.
Exclusion Criteria:
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Active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index < 0.70).
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Walking difficulty
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Neurologic diseases of the lower limbs
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Presenting or likely to present a contraindication to thermal treatments, with planned surgery;
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Having already benefited from a thermal treatment whatever the indication during the last 6 months
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Chronic infectious disease, cancer, heart, kidney or liver failure;
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Pregnant, breastfeeding women or women planning a pregnancy within the year;
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Persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent;
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Patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up;
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Living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site;
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Already included in a clinical trial or in the exclusion period of a clinical trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CEN Biotech
- TOWN HALL OF ROYAT
Investigators
- Principal Investigator: Geoffroy COUCHET, PD, Private Practitioner
Study Documents (Full-Text)
None provided.More Information
Publications
- C1688