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decision to stop the study because of enrollment difficulties.
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The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | immediate thermal cure (1st year) |
|
| 2 | Sham Comparator | late thermal cure (2 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thermal cure | Drug | thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence at 1 year of a severe post-thrombotic syndrome clinically defined. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Post-thrombotic syndrome at 2 years; | 2 years | |
| Quality of life: CIVIQ Scale; | inclusion, 1, 2 years before and after thermal cure | |
| Intensity of the symptoms of venous insufficiency auto evaluation by patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François POIRAULT, Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etablissement thermal | Argelès-Gazost | 65400 | France | |||
| Etablissement thermal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8644983 | Background | Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001. | |
| 15733061 | Background | Kahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. doi: 10.1111/j.1538-7836.2005.01216.x. Epub 2005 Feb 23. |
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| late thermal cure | Drug | thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years |
|
| monthly |
| Deep venous reflux (evaluated by echo-doppler); | inclusion, 1 and 2 years |
| Persistence of a residual thrombus (echo-doppler); | inclusion, 1 and 2 years |
| Correlation between clinical evolution and echo-doppler evolution of the venous after-effects; | 1 year |
| Benefit of a late cure at 2 years. | 2 years |
| Bagnoles-de-l'Orne |
| 61140 |
| France |
| Etablissement thermal | Barbotan-les-Thermes | 32150 | France |
| L'avenue | Dax | 40100 | France |
| Sarrailh | Dax | 40100 | France |
| Le Splendid | Dax | 40101 | France |
| Les thermes | Dax | 40101 | France |
| Le miradour | Dax | 40103 | France |
| Les arènes | Dax | 40103 | France |
| Bérot | Dax | 40104 | France |
| Les écureuils | Dax | 40104 | France |
| Dax thermal | Dax | 40105 | France |
| Foch | Dax | 40105 | France |
| Borda | Dax | 40106 | France |
| Saint-Pierre | Dax | 40106 | France |
| Le Grand Hôtel | Dax | 40108 | France |
| Le Regina | Dax | 40108 | France |
| Etablissement thermal | Évian-les-Bains | 23110 | France |
| Domaine d'heurteboise | Jonzac | 17503 | France |
| Etablissement thermal | La Léchère | 73260 | France |
| Etablissement thermal | Luxeuil-les-Bains | 70300 | France |
| Etablissement thermal | Luz-Saint-Sauveur | 65120 | France |
| Etablissement thermal | Rochefort | 17300 | France |
| Caliceo | Saint-Paul-lès-Dax | 40990 | France |
| Christus | Saint-Paul-lès-Dax | 40990 | France |
| Chênes | Saint-Paul-lès-Dax | 40990 | France |
| Etablissmeent thermal | Saubusse-les-bains | 40180 | France |
| 15791546 | Background | Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. doi: 10.1053/j.semvascsurg.2004.12.002. |
| 15784766 | Background | Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82. doi: 10.7863/jum.2005.24.4.475. |
| 8993100 | Background | Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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