Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450606
Status:
COMPLETED
Last Update Posted:
2008-05-21
First Post:
2007-03-21
Brief Title:
The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-05
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:
This study will check the efficacy of balneological therapy of bathing in Dead Sea fountain waters over a 6 week period on a twice a week basis overall 12 treatments in patients suffering from osteoarthritis of the knees
Detailed Description:
Since stay in the Dead Sea for a long period of time is an expensive matter it is important to determine whether twice a week treatments can be as beneficiary as two straight weeks of treatments as was shown to be effective in previous studies
Our study will follow the patients for a longer period of time 6 months than was done in previous studies
An additional advantage will be separating the therapeutical effect of our specific treatment from the therapeutical effect of being in a comfortable hotel away from the daily nuisances for 2 weeks which by itself has been shown to be pain relieving in patients suffering from rheumatic diseases
Our study will take 50 patients suffering from Osteoarthritis of the knees and divide them in to 2 equal groups One group will be treated twice a week with thermo-mineral baths at the temperature of 35-36 degrees Celsius for approximately 20 minutes The other group will be treated twice a week with hot sweet water tub without the water jets of the same temperature and for the same length of time
Both groups will change nothing in their current medical treatment
The patients will be examined at 5 points during this study a few days before their first treatment right after their last treatment after 6 weeks after one month after 3 months and after 6 months
All examination will be performed in the Soroka University Medical Center
The clinical indexes and questionnaires which would be filled during this trial will be
1 WOMAC index
2 Lequesnes index
3 Visual analogue scale by the patient
4 Visual analogue scale by the doctor
5 SF 36 and Health assessment questionnaire HAQ
Our study will follow the patients for a longer period of time 6 months than was done in previous studies
An additional advantage will be separating the therapeutical effect of our specific treatment from the therapeutical effect of being in a comfortable hotel away from the daily nuisances for 2 weeks which by itself has been shown to be pain relieving in patients suffering from rheumatic diseases
Our study will take 50 patients suffering from Osteoarthritis of the knees and divide them in to 2 equal groups One group will be treated twice a week with thermo-mineral baths at the temperature of 35-36 degrees Celsius for approximately 20 minutes The other group will be treated twice a week with hot sweet water tub without the water jets of the same temperature and for the same length of time
Both groups will change nothing in their current medical treatment
The patients will be examined at 5 points during this study a few days before their first treatment right after their last treatment after 6 weeks after one month after 3 months and after 6 months
All examination will be performed in the Soroka University Medical Center
The clinical indexes and questionnaires which would be filled during this trial will be
1 WOMAC index
2 Lequesnes index
3 Visual analogue scale by the patient
4 Visual analogue scale by the doctor
5 SF 36 and Health assessment questionnaire HAQ
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