EVENT: Hydrotherapy and Deep Venous Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348907
Recruitment Status : Terminated (decision to stop the study because of enrollment difficulties.)
First Posted : July 6, 2006
Last Update Posted : November 1, 2007
Information provided by:
Association Francaise pour la Recherche Thermale

Brief Summary:
The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

Condition or disease Intervention/treatment Phase
Pain Deep Venous Thrombosis Drug: thermal cure Drug: late thermal cure Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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.
Study Start Date : July 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
immediate thermal cure (1st year)
Drug: thermal cure
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam

Sham Comparator: 2
late thermal cure (2 years)
Drug: late thermal cure
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years

Primary Outcome Measures :
  1. Presence at 1 year of a severe post-thrombotic syndrome clinically defined. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Post-thrombotic syndrome at 2 years; [ Time Frame: 2 years ]
  2. Quality of life: CIVIQ Scale; [ Time Frame: inclusion, 1, 2 years before and after thermal cure ]
  3. Intensity of the symptoms of venous insufficiency auto evaluation by patient [ Time Frame: monthly ]
  4. Deep venous reflux (evaluated by echo-doppler); [ Time Frame: inclusion, 1 and 2 years ]
  5. Persistence of a residual thrombus (echo-doppler); [ Time Frame: inclusion, 1 and 2 years ]
  6. Correlation between clinical evolution and echo-doppler evolution of the venous after-effects; [ Time Frame: 1 year ]
  7. Benefit of a late cure at 2 years. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • both sexes;
  • 18 years old and more;
  • clinical indication of thermal cure (first phase of deep venous thrombosis authenticated by unilateral venous echo-doppler
  • curative anticoagulant treatment more than 3 month;
  • oedema and/or spontaneous pain with functional discomfort;
  • available for a thermal cure during 18 days and a follow-up period of 36 month;
  • voluntary to participate to the study, informed consent form signed after appropriate information;
  • affiliation to the social security system or equivalent;
  • no previous participation to a thermal cure (in the indication of phlebology)

Exclusion Criteria:

  • isolate distal thrombosis;
  • asymptomatic thrombosis;
  • cutaneous ulcer of lower limb;
  • refusal to consent;
  • refusal to benefit of thermal cure;
  • contra-indication to hydrotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348907

Etablissement thermal
Argeles-Gazost, France, 65400
Etablissement thermal
Bagnoles de l'orne, France, 61140
Etablissement thermal
Barbotan-les-thermes, France, 32150
DAX, France, 40100
Dax, France, 40100
Le Splendid
Dax, France, 40101
Les thermes
Dax, France, 40101
Le miradour
Dax, France, 40103
Les arènes
DAX, France, 40103
Dax, France, 40104
Les écureuils
Dax, France, 40104
Dax thermal
Dax, France, 40105
Dax, France, 40105
Dax, France, 40106
Dax, France, 40106
Le Grand Hôtel
Dax, France, 40108
Le Regina
Dax, France, 40108
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
Saint-Paul-les-Dax, France, 40990
Saint-Paul-les-Dax, France, 40990
Saint-Paul-les-Dax, France, 40990
Etablissmeent thermal
Saubusse-les-bains, France, 40180
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Principal Investigator: François POIRAULT, Dr

Publications: Identifier: NCT00348907     History of Changes
Other Study ID Numbers: DCIC 05 45
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by Association Francaise pour la Recherche Thermale:
CIVIQ quality of life

Additional relevant MeSH terms:
Venous Thrombosis
Postthrombotic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency