EVENT: Hydrotherapy and Deep Venous Thrombosis

Pain Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00348907
• Other study ID #: DCIC 05 45
• Status: Terminated
• Phase: Phase 3
• First received: July 4, 2006
• Last updated: October 31, 2007
• Start date: July 2006
• Est. completion date: December 2006

Study information

• Verified date: October 2007
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Pain
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
France	Etablissement thermal	Argeles-Gazost
France	Etablissement thermal	Bagnoles de l'orne
France	Etablissement thermal	Barbotan-les-thermes
France	Bérot	Dax
France	Borda	Dax
France	Dax thermal	Dax
France	Foch	Dax
France	L'avenue	DAX
France	Le Grand Hôtel	Dax
France	Le miradour	Dax
France	Le Regina	Dax
France	Le Splendid	Dax
France	Les arènes	DAX
France	Les écureuils	Dax
France	Les thermes	Dax
France	Saint-Pierre	Dax
France	Sarrailh	Dax
France	Etablissement thermal	Evian-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-sur-mer
France	Caliceo	Saint-Paul-les-Dax
France	Chênes	Saint-Paul-les-Dax
France	Christus	Saint-Paul-les-Dax
France	Etablissmeent thermal	Saubusse-les-bains

Sponsors (1)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. Epub 2005 Feb 23. — View Citation

Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence at 1 year of a severe post-thrombotic syndrome clinically defined.		1 year
Secondary	Post-thrombotic syndrome at 2 years;		2 years
Secondary	Quality of life: CIVIQ Scale;		inclusion, 1, 2 years before and after thermal cure
Secondary	Intensity of the symptoms of venous insufficiency auto evaluation by patient		monthly
Secondary	Deep venous reflux (evaluated by echo-doppler);		inclusion, 1 and 2 years
Secondary	Persistence of a residual thrombus (echo-doppler);		inclusion, 1 and 2 years
Secondary	Correlation between clinical evolution and echo-doppler evolution of the venous after-effects;		1 year
Secondary	Benefit of a late cure at 2 years.		2 years