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

This study has been completed.
Sponsor:
Collaborator:
Lot Spa Hotel Dead Sea
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00450606
First received: March 21, 2007
Last updated: May 20, 2008
Last verified: May 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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:

  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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on July 23, 2014