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Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

Primary Purpose

Balneology

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Crenobalneotherapy
Sponsored by
Centre de Recherche Rhumatologique et Thermal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Balneology focused on measuring Chronic venous insufficiency, Varicose vein, Crenobalneotherapy, Balneotherapy, Spa therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Crenobalneotherapy

    control group

    Arm Description

    18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle.

    patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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).
    civic
    evolution of civic scale
    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).
    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
    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)
    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
    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

    Full Information

    First Posted
    September 29, 2013
    Last Updated
    October 6, 2013
    Sponsor
    Centre de Recherche Rhumatologique et Thermal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01956318
    Brief Title
    Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency
    Official Title
    Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre de Recherche Rhumatologique et Thermal

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Balneology
    Keywords
    Chronic venous insufficiency, Varicose vein, Crenobalneotherapy, Balneotherapy, Spa therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Crenobalneotherapy
    Arm Type
    Experimental
    Arm Description
    18 days of balneotherapy session in 3 weeks. Patients are also delivered a booklet with advice on lifestyle.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    patients are allowed to continue their usual drugs, compression therapy and are delivered a booklet with advice on lifestyle.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Crenobalneotherapy
    Other Intervention Name(s)
    Crenotherapy, Balneotherapy, Spa therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    number of patient with 20% improvement of CIVIC scale at 3 months
    Description
    Primary outcome is the number of patient with 20% improvement in quality of life (CIVIC scale) at 3 months
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    CIVIC
    Description
    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
    Title
    civic
    Description
    evolution of civic scale
    Time Frame
    1 & 3 months
    Title
    Rutherford severity score
    Description
    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
    Title
    PASS
    Description
    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
    Title
    opinion of patient and practitionner
    Description
    Opinion of patient and practitioner is determined on a 5 point Lickert scale (very aggravated, aggravated, unchanged, improved and very improved)
    Time Frame
    1 & 3 months
    Title
    associated treatment
    Description
    Drug consumption is estimated on the last 3 days prior to the evaluation. Surgery, hospitalization for venous insufficiency and adherence to compression therapy
    Time Frame
    1 & 3 months
    Title
    side effects
    Description
    side effects are collected by therapists and assessor. we collected the number of patients with side effects and the type of side effect
    Time Frame
    week 1 & 3. 1 & 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25147013
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

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