Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

Phase 3

Completed

• Conditions: Balneology

• Registration Number: NCT01956318
• Lead Sponsor: Centre de Recherche Rhumatologique et Thermal

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2013-09-29
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-06
• Last Update Submitted: 2013-10-06
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
CIVIC	1 month	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).
civic	1 & 3 months	evolution of civic scale
Rutherford severity score	1 & 3 months	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).
PASS	1 & 3 months	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
opinion of patient and practitionner	1 & 3 months	Opinion of patient and practitioner is determined on a 5 point Lickert scale (very aggravated, aggravated, unchanged, improved and very improved)
associated treatment	1 & 3 months	Drug consumption is estimated on the last 3 days prior to the evaluation. Surgery, hospitalization for venous insufficiency and adherence to compression therapy
side effects	week 1 & 3. 1 & 3 months	side effects are collected by therapists and assessor. we collected the number of patients with side effects and the type of side effect