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Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

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ClinicalTrials.gov Identifier: NCT01956318
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
FORESTIER Romain, Centre de Recherche Rhumatologique et Thermal

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

Condition or disease Intervention/treatment Phase
Balneology Behavioral: Crenobalneotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
Study Start Date : July 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

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:
  • Crenotherapy
  • Balneotherapy
  • 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.



Primary Outcome Measures :
  1. number of patient with 20% improvement of CIVIC scale at 3 months [ Time Frame: 3 months ]
    Primary outcome is the number of patient with 20% improvement in quality of life (CIVIC scale) at 3 months


Secondary Outcome Measures :
  1. CIVIC [ Time Frame: 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).

  2. civic [ Time Frame: 1 & 3 months ]
    evolution of civic scale

  3. Rutherford severity score [ Time Frame: 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).

  4. PASS [ Time Frame: 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

  5. opinion of patient and practitionner [ Time Frame: 1 & 3 months ]
    Opinion of patient and practitioner is determined on a 5 point Lickert scale (very aggravated, aggravated, unchanged, improved and very improved)

  6. associated treatment [ Time Frame: 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

  7. side effects [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: FORESTIER Romain, President of the research center, Centre de Recherche Rhumatologique et Thermal
ClinicalTrials.gov Identifier: NCT01956318     History of Changes
Other Study ID Numbers: Thermes2010
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by FORESTIER Romain, Centre de Recherche Rhumatologique et Thermal:
Chronic venous insufficiency
Varicose vein
Crenobalneotherapy
Balneotherapy
Spa therapy

Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases