NCT05220527

Effects of Knee Injections on Patients With Knee Osteoarthritis

Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A total of 60 patients will be collected. The participants will be randomized into three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections. Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.

Conditions

• Knee Osteoarthritis
• Injection
• Effect of Drug

Interventions

Type	Name	Description
DRUG	Triamcinolone plus hyruan	triamcinolone plus hyruan injections, one time per week, for 3 weeks
DRUG	vitagen plus hyruan	vitagen plus hyruan injections, one time per week, for 3 weeks
DRUG	normal saline plus hyruan	normal saline plus hyruan injections, one time per week, for 3 weeks

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2022-02-02
• Last updated: 2022-02-02

Locations

1 site across 1 country: Taiwan