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Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis

17. november 2019 oppdatert av: Ru-Lan Hsieh, Taipei Medical University

Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: a Double-blind, Randomized-controlled Clinical Trial

Using double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability, and Health.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months

Exclusion Criteria:

  • major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: steroid plus hyaluronic acid
steroid plus hyaluronic acid injection, one time per week, for 3 weeks
Legemiddel: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
compare the immediate effect (one week after 3 times of injections), short-term effects (one month and three months after 3 times of injections), and midterm effect (6 months after 3 times of injections).
Aktiv komparator: dextrose plus hyaluronic acid
dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
Legemiddel: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
compare the immediate effect (one week after 3 times of injections), short-term effects (one month and three months after 3 times of injections), and midterm effect (6 months after 3 times of injections).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Osteoarthritis index
Tidsramme: changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range: 0-100, higher scores mean a worse outcome
assess knee osteoarthritis related performance
changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range: 0-100, higher scores mean a worse outcome

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Balance
Tidsramme: changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome
Berg Balance scale
changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome
physical functional performance-walking
Tidsramme: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
10 meters normal and fast walking speed
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-stairs climbing
Tidsramme: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
time for up and down stairs
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-chair raising
Tidsramme: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
5 repeated chair-rising time
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
physical functional performance-balance
Tidsramme: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
timed up and go test
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Knee Injury and Osteoarthritis Outcome Score
Tidsramme: changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-100, higher scores mean at better outcome
assess osteoarthritis of knee related function
changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-100, higher scores mean at better outcome
Doppler resistance index
Tidsramme: changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance
assess knee blood vessel resistance
changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Taipei Medical University

Samarbeidspartnere

Shin Kong Wu Ho-Su Memorial Hospital

Etterforskere

  • Studiestol: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

11. november 2019

Primær fullføring (Forventet)

31. juli 2020

Studiet fullført (Forventet)

31. juli 2020

Datoer for studieregistrering

Først innsendt

10. november 2019

Først innsendt som oppfylte QC-kriteriene

13. november 2019

Først lagt ut (Faktiske)

18. november 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MOST 108-2314-B-341-003

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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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