The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees - Full Text View

Sponsors and Collaborators:	Soroka University Medical Center Lot Spa Hotel Dead Sea
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00450606

Purpose

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.

Condition	Intervention
Osteoarthritis of the Knees	Procedure: Balneotherapy and hydrotherapy

MedlinePlus related topics: Drinking Water Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Soroka University Medical Center:

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

Estimated Enrollment:	50
Study Start Date:	March 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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)

Eligibility

Genders Eligible for Study:

Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450606

Sponsors and Collaborators

Soroka University Medical Center

Lot Spa Hotel Dead Sea

Investigators

Principal Investigator:

Shaul Sukenik, Prof.

Soroka University Medical Center

More Information

No publications provided

Study ID Numbers:	SOR450007CTIL
Study First Received:	March 21, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00450606 History of Changes
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Osteoarthritis, Knee
Death
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009