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

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

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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