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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
Soroka University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knees

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

    First Posted
    March 21, 2007
    Last Updated
    May 20, 2008
    Sponsor
    Soroka University Medical Center
    Collaborators
    Lot Spa Hotel Dead Sea
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    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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