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

20. maj 2008 opdateret af: Soroka University Medical Center
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.

Studieoversigt

Status

Afsluttet

Detaljeret 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:

  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)

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Shaul Sukenik, Prof., Soroka University Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Primær færdiggørelse (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

21. marts 2007

Først indsendt, der opfyldte QC-kriterier

21. marts 2007

Først opslået (Skøn)

22. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. maj 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2008

Sidst verificeret

1. maj 2008

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SOR450007CTIL

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Osteoarthritis of the Knees

Kliniske forsøg med Balneotherapy and hydrotherapy

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