Clinical trial NCT00348777: THERMARTHROSE: Gonarthrosis and Water Cure
Official title: Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Pain
Keywords: Visual analogic Scale of pain
Womac indice
SF-36 quality of life
Hydrotherapy
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
First posted: 2006-07-06
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ACR criteria: knee pain and one of the tree following conditions: Age \> 50 years, Morning stiffness\< 30 minutes and articular crackling.
* osteophytes visible on knee radiography.
* knee radiography less than 3 years old: face, schuss, axial of kneecap cliché.
* Actual gonarthrosis intensity on Visual Analogic Scale \> or = 30mm.

Exclusion Criteria:

* arthrosis limited to the femoro-patellar compartments.
* severe depressive syndrome, psychosis.
* Thermal cure less than 6 month before.
* Contra-indication or predictable inability to tolerate thermal cure.
* Profession lied to hydrotherapy.
* previous knee treatments:

  * massage, physiotherapy and acupuncture since less than 1 month;
  * infiltration since less than 3 months;
  * NSAI since less than 5 days;
  * analgesic since less than 12 hours;
  * modification in the medicinal anti-arthrosis treatment since less than 3 months.

Primary outcomes:
measure: the more small change clinically relevant of the WOMAC indice and/or of pain.
timeFrame: at 6 months
Secondary outcomes:
measure: WOMAC indice and pain (EVA)
timeFrame: at inclusion and 1, 3, 6 and 9 months
measure: The clinically acceptable symptom for the patient
timeFrame: at 6 months
measure: Clinical evaluation
timeFrame: at inclusion and 1, 3 and 6 months
measure: Opinion of the patient and the physician
timeFrame: at 1, 3 and 6 months
measure: Quality of life: questionnaire SF-36
timeFrame: inclusion and 1, 3, 6 and 9 months
measure: 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)
timeFrame: inclusion and 1,3,6 months
Other outcomes:
Locations:
city: Balaruc-les-Bains
country: France
facility: Cabinet médical
city: Chambery
country: France
facility: Cabinet Médical
city: DAX
country: France
facility: Hôpital thermal
Study officials:
affiliation: Président du Centre de Recherches Rhumatologiques et Thermales, Aix-les-Bains, France
name: Romain FORESTIER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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