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

T

Taipei Medical University

Status and phase

Unknown
Phase 4

Conditions

Knee Osteoarthritis

Treatments

Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis

Study type

Interventional

Funder types

Other

Identifiers

NCT04165902
MOST 108-2314-B-341-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

steroid plus hyaluronic acid
Experimental group
Description:
steroid plus hyaluronic acid injection, one time per week, for 3 weeks
Treatment:
Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
dextrose plus hyaluronic acid
Active Comparator group
Description:
dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
Treatment:
Drug: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis

Trial contacts and locations

1

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Central trial contact

Ru-Lan Hsieh, MD

Data sourced from clinicaltrials.gov

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