The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450606
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : May 21, 2008
Lot Spa Hotel Dead Sea
Information provided by:
Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knees Procedure: Balneotherapy and hydrotherapy Not Applicable

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. Lequesne's index
  3. Visual analogue scale by the patient
  4. Visual analogue scale by the doctor
  5. SF 36 and Health assessment questionnaire (HAQ)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. Quality of life evaluation at one, three and six months
  2. Functional state of the patient at one, three and six months
  3. Osteoarthritis severity at one, three and six months

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00450606

Sponsors and Collaborators
Soroka University Medical Center
Lot Spa Hotel Dead Sea
Principal Investigator: Shaul Sukenik, Prof. Soroka University Medical Center Identifier: NCT00450606     History of Changes
Other Study ID Numbers: SOR450007CTIL
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases