EVENT: Hydrotherapy and Deep Venous Thrombosis

Phase 3

Terminated

• Conditions: Pain; Deep Venous Thrombosis
• Interventions: Drug: thermal cure; Drug: late thermal cure

• Registration Number: NCT00348907
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-04
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Study Completion: 2006-12
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-31
• Last Update Posted: 2007-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	thermal cure	immediate thermal cure (1st year)
2	late thermal cure	late thermal cure (2 years)

Primary Outcome Measures

Name	Time	Method
Presence at 1 year of a severe post-thrombotic syndrome clinically defined.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Caliceo; 🇫🇷 Saint-Paul-les-Dax, France

L'avenue; 🇫🇷 DAX, France

Christus; 🇫🇷 Saint-Paul-les-Dax, France

Sarrailh; 🇫🇷 Dax, France

Les arènes; 🇫🇷 DAX, France

Saint-Pierre; 🇫🇷 Dax, France

Foch; 🇫🇷 Dax, France

Le Grand Hôtel; 🇫🇷 Dax, France

Le Splendid; 🇫🇷 Dax, France

Etablissement thermal; 🇫🇷 Rochefort-sur-mer, France

Les thermes; 🇫🇷 Dax, France

Borda; 🇫🇷 Dax, France

Le miradour; 🇫🇷 Dax, France

Bérot; 🇫🇷 Dax, France

Les écureuils; 🇫🇷 Dax, France

Dax thermal; 🇫🇷 Dax, France

Chênes; 🇫🇷 Saint-Paul-les-Dax, France

Le Regina; 🇫🇷 Dax, France

Domaine d'heurteboise; 🇫🇷 Jonzac, France

Etablissmeent thermal; 🇫🇷 Saubusse-les-bains, France