Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Balneology
• Intervention / Treatment: Behavioral: Crenobalneotherapy

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Crenobalneotherapy; 18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle.	Behavioral: Crenobalneotherapy; 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.; Other Names: Balneotherapy; Crenotherapy; Spa therapy
NO_INTERVENTION: control group; patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 month
civic	evolution of civic scale	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).	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	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)	1 & 3 months
associated treatment	Drug consumption is estimated on the last 3 days prior to the evaluation. Surgery, hospitalization for venous insufficiency and adherence to compression therapy	1 & 3 months
side effects	side effects are collected by therapists and assessor. we collected the number of patients with side effects and the type of side effect	week 1 & 3. 1 & 3 months

Collaborators and Investigators

• Sponsor: Centre de Recherche Rhumatologique et Thermal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: September 29, 2013
• First Submitted That Met QC Criteria: October 6, 2013
• First Posted (ESTIMATE): October 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 6, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Balneotherapy; Spa therapy; Chronic venous insufficiency; Varicose vein; Crenobalneotherapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: Thermes2010