Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

NCT01956318 | Completed Phase 3

• 1 other identifier: Thermes2010
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.

Conditions

Balneology

Keywords

Chronic venous insufficiency; Varicose vein; Crenobalneotherapy; Balneotherapy; Spa therapy

Outcome Measures

Primary Outcomes (1)

• number of patient with 20% improvement of CIVIC scale at 3 months

  Primary outcome is the number of patient with 20% improvement in quality of life (CIVIC scale) at 3 months

  3 months

Secondary Outcomes (7)

• CIVIC

  1 month

• civic

  1 & 3 months

• Rutherford severity score

  1 & 3 months

• PASS

  1 & 3 months

• opinion of patient and practitionner

  1 & 3 months

Study Arms (2)

Crenobalneotherapy

EXPERIMENTAL

18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle.

Behavioral: Crenobalneotherapy

control group

NO INTERVENTION

patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle.

Interventions

Crenobalneotherapy BEHAVIORAL

18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center.

Also known as: Crenotherapy, Balneotherapy, Spa therapy

Crenobalneotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)
• Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months

You may not qualify if:

• pregnant women,
• contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
• surgery in the next three months,
• spa treatment in the previous 6 months,
• professional involvement with a spa resort

Sponsors & Collaborators

• Centre de Recherche Rhumatologique et Thermal: lead

Related Publications (1)

• Forestier RJ, Briancon G, Francon A, Erol FB, Mollard JM. Balneohydrotherapy in the treatment of chronic venous insufficiency. Vasa. 2014 Sep;43(5):365-71. doi: 10.1024/0301-1526/a000374.

  PMID: 25147013 DERIVED

MeSH Terms

Conditions

Varicose Veins

Interventions

Balneology

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the research center

Study Record Dates

• First Submitted: September 29, 2013
• First Posted: October 8, 2013
• Study Start: July 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 8, 2013

Record last verified: 2013-10