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Completed

NCT Number: NCT01956318

Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

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

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Key information

Conditions

Balneology Cardiovascular Diseases Varicose Veins Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crenobalneotherapy

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre de Recherche Rhumatologique et Thermal

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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