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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04165902
• Other study ID #: MOST 108-2314-B-341-003
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 11, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2019
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886-2984161201
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis index	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
Secondary	Balance	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
Secondary	physical functional performance-walking	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
Secondary	physical functional performance-stairs climbing	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
Secondary	physical functional performance-chair raising	5 repeated chair-rising time	change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Secondary	physical functional performance-balance	timed up and go test	change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Secondary	Knee Injury and Osteoarthritis Outcome Score	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
Secondary	Doppler resistance index	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