The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees
Primary Purpose
Osteoarthritis of the Knees
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Balneotherapy and hydrotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knees
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from Osteoarthritis of the knees according to the conventional measurements of the American College of Rheumatology and who are treated in the Rheumatological clinics of the Soroka University Medical Center
Exclusion Criteria:
- Patients suffering from any other rheumatological disease other than osteoarthritis
- Patients that were previously treated with hydrotherapy or balneotherapy
- Patients suffering from balance disorders or loss of consciousness disorders such as epilepsy, arrhythmias etc.
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00450606
First Posted
March 21, 2007
Last Updated
May 20, 2008
Sponsor
Soroka University Medical Center
Collaborators
Lot Spa Hotel Dead Sea
1. Study Identification
Unique Protocol Identification Number
NCT00450606
Brief Title
The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
Collaborators
Lot Spa Hotel Dead Sea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
WOMAC index
Lequesne's index
Visual analogue scale by the patient
Visual analogue scale by the doctor
SF 36 and Health assessment questionnaire (HAQ)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knees
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Balneotherapy and hydrotherapy
Primary Outcome Measure Information:
Title
Quality of life evaluation at one, three and six months
Title
Functional state of the patient at one, three and six months
Title
Osteoarthritis severity at one, three and six months
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
Patients suffering from Osteoarthritis of the knees according to the conventional measurements of the American College of Rheumatology and who are treated in the Rheumatological clinics of the Soroka University Medical Center
Exclusion Criteria:
Patients suffering from any other rheumatological disease other than osteoarthritis
Patients that were previously treated with hydrotherapy or balneotherapy
Patients suffering from balance disorders or loss of consciousness disorders such as epilepsy, arrhythmias etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaul Sukenik, Prof.
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees
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