The main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.
Gonarthrosis is a frequent pathology and the prevalence increase with age (prevalence: 6,1% in an adult population more than 30 years old and 40% after 75 years). It has a large impact on the quotidian life of the patients and it cause important costs for social protection. Relative to the treatment, numerous recommendations have been proposed (EULAR, ACR specifically). But no one of them recommends thermal treatment even if it is largely used in Europe and especially in France for the treatment of this pathology. Several prospective controlled randomized studies have evaluated the effect of the thermal treatments in rheumatology and some of them are relative, in part, to Gonarthrosis. So, we conduct a phase III randomized, controlled, single blind study evaluating the therapeutic effect at 6 month of a thermal cure on gonarthrosis. In a situation of physical treatment, it's impossible to use a placebo as control: blind can't be respected. Whatever the methodology employed, non blind of the patient create a bias. So, we hope that the Zelen method for randomization will reduce the bias due to the dissatisfaction of the patients in the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
462
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
access to watering place for movement in swimming pool, sauna and hammam.
Cabinet médical
Balaruc-les-Bains, France
Cabinet Médical
Chambéry, France
Hôpital thermal
Dax, France
the more small change clinically relevant of the WOMAC indice and/or of pain.
Time frame: at 6 months
WOMAC indice and pain (EVA)
Time frame: at inclusion and 1, 3, 6 and 9 months
The clinically acceptable symptom for the patient
Time frame: at 6 months
Clinical evaluation
Time frame: at inclusion and 1, 3 and 6 months
Opinion of the patient and the physician
Time frame: at 1, 3 and 6 months
Quality of life: questionnaire SF-36
Time frame: inclusion and 1, 3, 6 and 9 months
Treatments: medicinal consumption, physical treatments, hospitalization, consumption of cares getting back by the Medicaid of Savoie (CPAM, only for the study centre of Aix-les-Bains)
Time frame: inclusion and 1,3,6 months
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