Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency
NCT ID: NCT01956318
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
99 participants
INTERVENTIONAL
2010-07-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Crenobalneotherapy
18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle.
Crenobalneotherapy
18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center.
control group
patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle.
No interventions assigned to this group
Interventions
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Crenobalneotherapy
18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months
Exclusion Criteria
* contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
* surgery in the next three months,
* spa treatment in the previous 6 months,
* professional involvement with a spa resort
18 Years
80 Years
ALL
No
Sponsors
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Centre de Recherche Rhumatologique et Thermal
OTHER
Responsible Party
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FORESTIER Romain
President of the research center
References
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Forestier RJ, Briancon G, Francon A, Erol FB, Mollard JM. Balneohydrotherapy in the treatment of chronic venous insufficiency. Vasa. 2014 Sep;43(5):365-71. doi: 10.1024/0301-1526/a000374.
Other Identifiers
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Thermes2010
Identifier Type: -
Identifier Source: org_study_id