EVENT: Hydrotherapy and Deep Venous Thrombosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs.

Conditions
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Pain, Deep Venous Thrombosis

Intervention / Treatment
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* Drug: thermal cure
* Drug: late thermal cure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>immediate thermal cure (1st year) | Drug: thermal cure<br>* thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam<br>|
| Sham Comparator: 2<br>late thermal cure (2 years) | Drug: late thermal cure<br>* thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence at 1 year of a severe post-thrombotic syndrome clinically defined. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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doppler, CIVIQ quality of life, Hydrotherapy, anticoagulants