Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

Balneology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956318
• Other study ID #: Thermes2010
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2013
• Last updated: October 6, 2013
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2013
• Source: Centre de Recherche Rhumatologique et Thermal
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Balneology
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche Rhumatologique et Thermal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	civic	evolution of civic scale	1 & 3 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes