Medical Hydrology and Balneology: Environmental Aspects

Crenobalneotherapy in the treatment of chronic
venous insufficiency. Preliminary results of a
randomized clinical trial
Forestier R(1), Briacon G (1) , Mollard J (1) , Françon A (1)
(1) Centre for Rheumatology and Balneotherapy Research, Aix Les Bains, France
romain.forestier@wanadoo.fr
Introduction and Objectives
This study evaluates the effect of spa therapy on quality of life for patients with
chronic venous insufficiency.
Trial design.
Randomized clinical trial comparing spa therapy + usual care versus waiting list
+ usual care.
Materials and Methods
Participants
Participants Patients between 18 - 80, with chronic venous insufficiency stage 3
or 4 in the Clinical Etiology Anatomic Pathophysiology (CEAP) classification.
Patients were recruited by press announcement.
Intervention
Spa therapy group received 18 days of treatment in Aix-Les-Bains spa center
and continued their usual care. Control group continued their usual care during the
therapy and received spa treatment after the end of the study. Spa treatment was
Kneipp therapy, walking 10’ in a special pool at 28°C with underwater jets, massage
& bath in tub at 30°C.
Objective
The spa treatment + usual care is superior to usual care alone.
Outcome
Main judgment criteria is the number of patient with 20% improvement of the
Chronic Venous Insufficiency Questionnaire (CIVIC2) at 3 months.
Secondary outcomes are: quality of life CIVIC2, improvement in Rutherford
score, associated treatment, patients acceptable symptom state (PASS), opinion of
patient and practitioner (senior specialist of chronic venous insufficiency), side
effects.
Randomisation
By blocks of random size (6, 8 or 10 patients). Allocation concealment was performed.
Balnea
2012, núm. 6, 68-69
68
ISBN: 978-84-669-1887-0
978-84-669-3482-4