The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees
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|ClinicalTrials.gov Identifier: NCT00450606|
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : May 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knees||Procedure: Balneotherapy and hydrotherapy||Not Applicable|
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:
- WOMAC index
- Lequesne's index
- Visual analogue scale by the patient
- Visual analogue scale by the doctor
- SF 36 and Health assessment questionnaire (HAQ)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2007|
- Quality of life evaluation at one, three and six months
- Functional state of the patient at one, three and six months
- Osteoarthritis severity at one, three and six months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450606
|Principal Investigator:||Shaul Sukenik, Prof.||Soroka University Medical Center|