A Phase 3 interventional study of thermal cure and late thermal cure in Pain and Deep Venous Thrombosis, sponsored by Association Francaise pour la Recherche Thermale. Terminated at 27 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-01.
Sponsored by Association Francaise pour la Recherche Thermale · Phase 3, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Association Francaise pour la Recherche Thermale is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
immediate thermal cure (1st year)
Drug: thermal cure
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
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years
Presence at 1 year of a severe post-thrombotic syndrome clinically defined.
Time frame: 1 year
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
This study is terminated, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Association Francaise pour la Recherche Thermale