Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis
17 november 2019 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: steroid plus hyaluronic acid
steroid plus hyaluronic acid injection, one time per week, for 3 weeks
|
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).
|
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Aktiv komparator: dextrose plus hyaluronic acid
dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis index
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Balance
Tidsram: 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
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Berg Balance scale
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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
Tidsram: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
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10 meters normal and fast walking speed
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change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
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|
physical functional performance-stairs climbing
Tidsram: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
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time for up and down stairs
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change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
|
physical functional performance-chair raising
Tidsram: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
5 repeated chair-rising time
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change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
|
physical functional performance-balance
Tidsram: 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
Tidsram: 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
|
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Doppler resistance index
Tidsram: 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
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assess knee blood vessel resistance
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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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
11 november 2019
Primärt slutförande (Förväntat)
31 juli 2020
Avslutad studie (Förväntat)
31 juli 2020
Studieregistreringsdatum
Först inskickad
10 november 2019
Först inskickad som uppfyllde QC-kriterierna
13 november 2019
Första postat (Faktisk)
18 november 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 november 2019
Senast verifierad
1 november 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MOST 108-2314-B-341-003
Plan för individuella deltagardata (IPD)
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NEJ
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