- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00450606
The Effects of Ambulatory Treatment at the Dead Sea on Osteoarthritis of the Knees
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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)
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Shaul Sukenik, Prof., Soroka University Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SOR450007CTIL
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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