Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348777
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2006-07-04
Brief Title:
THERMARTHROSE Gonarthrosis and Water Cure
Sponsor:
Association Francaise pour la Recherche Thermale
Organization:
Association Francaise pour la Recherche Thermale
Study Overview
Official Title:
Evaluation of the Effects of a Water Cure on Gonarthrosis Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 61 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 its impossible to use a placebo as control blind cant 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
In a situation of physical treatment its impossible to use a placebo as control blind cant 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None