Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

Phase 3CompletedNCT01956318

Centre de Recherche Rhumatologique et Thermal99 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Balneology

Interventions

CrenobalneotherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

CIVIC

Chronic Venous Insufficiency Questionnaire (CIVIQ 2) 20% improvement. disease-specific QOL score for patients with chronic venous disease. The total score is derived from 20 questions (items) that represent four QOL dimensions (of 3-9 items each): bodily pain, physical, social and psychological functioning. The possible scores for each item are as follows: 1, negative; 2, weak; 3, moderate; 4, strong; 5, severe. The total scores can therefore vary from 20 (no symptoms) to 100 (worse possible condition).

Time frame: 1 month

civic

evolution of civic scale

Time frame: 1 & 3 months

Rutherford severity score

clinical evaluation of severity taking into account 10 attributes: pain, varicose veins, venous edema, skin pigmentation, and adherence to compressive therapy, inflammation, induration, number, size and duration of active ulcer. Each attribute is scored 0 (minimum) to 2 (maximum).

Time frame: 1 & 3 months

PASS

PASS is measured by asking the patient if he/she feels he/she is in an acceptable clinical condition in terms of its venous insufficiency. We measure the number of patients with PASS

Time frame: 1 & 3 months

opinion of patient and practitionner

Opinion of patient and practitioner is determined on a 5 point Lickert scale (very aggravated, aggravated, unchanged, improved and very improved)

Data from ClinicalTrials.gov

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