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Sponsored by: |
Association Francaise pour la Recherche Thermale |
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Information provided by: | Association Francaise pour la Recherche Thermale |
ClinicalTrials.gov Identifier: | NCT00348907 |
The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.
Condition | Intervention | Phase |
---|---|---|
Pain Deep Venous Thrombosis |
Drug: thermal cure Drug: late thermal cure |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs. |
Enrollment: | 3 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2006 |
Arms | Assigned Interventions |
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1: Active Comparator
immediate thermal cure (1st year)
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Drug: thermal cure
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
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2: Sham Comparator
late thermal cure (2 years)
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Drug: late thermal cure
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years
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Venous thrombo-embolic disease (VTED) is a frequent pathology. The incidence is about 5 to 20 cases for 10000 persons each year, in a general population. The immediate risk is the pulmonary embolism potentially fatal. So, it justifies all the works in clinical research during the last years. Those studies allow many progresses, diagnostic and therapeutic, for the immediate undertaking of the patients. Despite that, VTED is a major problem of public health and the diminution of the mortality lied to VTED is one of the objectives of the French law relative to the politics of Public Health (August 2004). At more long-term, the post-thrombotic syndrome lead to an incapacitating pathology, which requires many cares. The frequency of the post-thrombotic syndrome is evaluated between 25 and 60% at middle-term (1 or 2 years). It depends of the studies and of the clinical primary end-points or vascular explorations. Rehabilitation has never been validated in this indication by studies with a correct methodology. Deep venous thrombosis (not in acute phase) is recognized as an indication for about 10 spa in France. But the specific or global benefit of this water cure is not clearly and scientifically proved. The importance of the venous pump of the calf and of the hydrostatic pressure in the physiopathology of the post-thrombotic syndrome make natural the use of balneotherapy for the prevention of this pathology for patients with severe deep venous thrombosis of lower limbs (proximal and obstruent). The venous thermal techniques have well-defined physiopathological targets. The haemodynamic and microcirculatory effects of some of them have been proved. The high degree of satisfaction of the patients that benefit from phlebological water cure every year in France indirectly shows the benefits that they feel. In those indications, prevention of the post-thrombotic syndrome is one of the well-recognize by the medical profession. For all that, there was not really validation of this indication with an acceptable methodology for the canons of the modern medicine. That is the reason why we undertake this randomized, single-blind controlled study with for main objective to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Etablissement thermal | |
Argeles-Gazost, France, 65400 | |
Etablissement thermal | |
Bagnoles de l'orne, France, 61140 | |
Etablissement thermal | |
Barbotan-les-thermes, France, 32150 | |
Les arènes | |
DAX, France, 40103 | |
L'avenue | |
DAX, France, 40100 | |
Bérot | |
Dax, France, 40104 | |
Borda | |
Dax, France, 40106 | |
Dax thermal | |
Dax, France, 40105 | |
Les écureuils | |
Dax, France, 40104 | |
Foch | |
Dax, France, 40105 | |
Le Grand Hôtel | |
Dax, France, 40108 | |
Le miradour | |
Dax, France, 40103 | |
Le Regina | |
Dax, France, 40108 | |
Etablissmeent thermal | |
Saubusse-les-bains, France, 40180 | |
Sarrailh | |
Dax, France, 40100 | |
Le Splendid | |
Dax, France, 40101 | |
Les thermes | |
Dax, France, 40101 | |
Etablissement thermal | |
Evian-les-bains, France, 23110 | |
Domaine d'heurteboise | |
Jonzac, France, 17503 | |
Etablissement thermal | |
La Léchère, France, 73260 | |
Etablissement thermal | |
Luxeuil-les-bains, France, 70300 | |
Etablissement thermal | |
Luz-saint-sauveur, France, 65120 | |
Etablissement thermal | |
Rochefort-sur-mer, France, 17300 | |
Christus | |
Saint-Paul-les-Dax, France, 40990 | |
Caliceo | |
Saint-Paul-les-Dax, France, 40990 | |
Chênes | |
Saint-Paul-les-Dax, France, 40990 | |
Saint-Pierre | |
Dax, France, 40106 |
Principal Investigator: | François POIRAULT, Dr | unaffiliated |
Study ID Numbers: | DCIC 05 45 |
Study First Received: | July 4, 2006 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00348907 History of Changes |
Health Authority: | France: Ministry of Health |
doppler CIVIQ quality of life Hydrotherapy anticoagulants |
Embolism and Thrombosis Anticoagulants Embolism Vascular Diseases Quality of Life |
Venous Thrombosis Pain Postthrombotic Syndrome Postphlebitic Syndrome Thrombosis |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Venous Thrombosis Thrombosis |