NCT00348777

THERMARTHROSE: Gonarthrosis and Water Cure

Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Association Francaise pour la Recherche Thermale · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Pain

Interventions

Type	Name	Description
DRUG	thermal cure	thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
DRUG	3 days access to watering place at 6 months	access to watering place for movement in swimming pool, sauna and hammam.

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-07-06
• Last updated: 2011-06-22

Locations

3 sites across 1 country: France