NCT00450606

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

Enrollment Period

9 months

First QC Date

March 21, 2007

Last Update Submit

May 20, 2008

Conditions

Osteoarthritis of the Knees

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Balneotherapy and hydrotherapyPROCEDURE

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BalneologyHydrotherapy

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Shaul Sukenik, Prof.

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 22, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Last Updated

May 21, 2008

Record last verified: 2008-05