Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

Centre de Recherche Rhumatologique et Thermal

Status and phase: Completed; Phase 3

Conditions: Balneology

Treatments: Behavioral: Crenobalneotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01956318

Thermes2010

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

99 participants in 2 patient groups

Crenobalneotherapy

Experimental group

Description:

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

Treatment:

Behavioral: Crenobalneotherapy

control group

No Intervention group

Description:

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