EVENT: Hydrotherapy and Deep Venous Thrombosis

This study has been terminated.
(decision to stop the study because of enrollment difficulties.)
Sponsor:
Information provided by:
Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:
NCT00348907
First received: July 4, 2006
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Association Francaise pour la Recherche Thermale:

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

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

Enrollment: 3
Study Start Date: July 2006
Study Completion Date: December 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348907

Locations
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
Saint-Pierre
Dax, France, 40106
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
Etablissmeent thermal
Saubusse-les-bains, France, 40180
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Investigators
Principal Investigator: François POIRAULT, Dr
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00348907     History of Changes
Other Study ID Numbers: DCIC 05 45
Study First Received: July 4, 2006
Last Updated: October 31, 2007
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014