Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis

Phase 4

• Conditions: Physical Activity
• Interventions: Other: hyaluronic acid; Other: hyaluronic acid combined corticosteroid

• Registration Number: NCT02625727
• Lead Sponsor: Taipei Medical University

Brief Summary

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.

Detailed Description

A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.

Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.

Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.

Study Timeline

• Study Start: 2015-08
• Status Verified: 2015-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Study First Posted: 2015-12-09
• Last Update Posted: 2015-12-09
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Osteoarthritis of knee with Kellgren/Lawrence grade II or III

Exclusion Criteria

• Who have implant in knee
• History of neurological deficit, such as stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyaluronic acid group	hyaluronic acid	hyaluronic acid injection
hyaluronic acid and corticosteroid group	hyaluronic acid combined corticosteroid	hyaluronic acid combined corticosteroid injection

Primary Outcome Measures

Name	Time	Method
physical activity	changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection

Secondary Outcome Measures

Name	Time	Method
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)	changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
functional performance (Knee injury and Osteoarthritis Outcome Score)	changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan