EVENT: Hydrotherapy and Deep Venous Thrombosis

NCT ID: NCT00348907

Last Updated: 2007-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2006-12-31

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.

Conditions

Pain; Deep Venous Thrombosis

Keywords

doppler; CIVIQ quality of life; Hydrotherapy; anticoagulants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

immediate thermal cure (1st year)

Group Type: ACTIVE_COMPARATOR

thermal cure

Intervention Type: DRUG

thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam

2

late thermal cure (2 years)

Group Type: SHAM_COMPARATOR

late thermal cure

Intervention Type: DRUG

thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years

Interventions

thermal cure

thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam

Intervention Type: DRUG

late thermal cure

thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role: lead

Principal Investigators

François POIRAULT, Dr

Role: PRINCIPAL_INVESTIGATOR

Locations

Etablissement thermal

Argelès-Gazost, , France

Etablissement thermal

Bagnoles-de-l'Orne, , France

Etablissement thermal

Barbotan-les-Thermes, , France

L'avenue

Dax, , France

Sarrailh

Dax, , France

Le Splendid

Dax, , France

Les thermes

Dax, , France

Le miradour

Dax, , France

Les arènes

Dax, , France

Bérot

Dax, , France

Les écureuils

Dax, , France

Dax thermal

Dax, , France

Foch

Dax, , France

Borda

Dax, , France

Saint-Pierre

Dax, , France

Le Grand Hôtel

Dax, , France

Le Regina

Dax, , France

Etablissement thermal

Évian-les-Bains, , France

Domaine d'heurteboise

Jonzac, , France

Etablissement thermal

La Léchère, , France

Etablissement thermal

Luxeuil-les-Bains, , France

Etablissement thermal

Luz-Saint-Sauveur, , France

Etablissement thermal

Rochefort, , France

Caliceo

Saint-Paul-lès-Dax, , France

Christus

Saint-Paul-lès-Dax, , France

Chênes

Saint-Paul-lès-Dax, , France

Etablissmeent thermal

Saubusse-les-bains, , France

Countries

France

References

Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.

Reference Type: BACKGROUND

PMID: 8644983 (View on PubMed)

Kahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. doi: 10.1111/j.1538-7836.2005.01216.x. Epub 2005 Feb 23.

Reference Type: BACKGROUND

PMID: 15733061 (View on PubMed)

Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. doi: 10.1053/j.semvascsurg.2004.12.002.

Reference Type: BACKGROUND

PMID: 15791546 (View on PubMed)

Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82. doi: 10.7863/jum.2005.24.4.475.

Reference Type: BACKGROUND

PMID: 15784766 (View on PubMed)

Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.

Reference Type: BACKGROUND

PMID: 8993100 (View on PubMed)

Other Identifiers

DCIC 05 45

Identifier Type: -

Identifier Source: org_study_id