Overview

This trial is active, not recruiting.

Condition physical activity
Treatment hyaluronic acid
Phase phase 4
Sponsor Taipei Medical University
Collaborator Shin Kong Wu Ho-Su Memorial Hospital
Start date August 2015
End date July 2016
Trial size 76 participants
Trial identifier NCT02625727, MOST104-2314-B-341-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
hyaluronic acid injection
hyaluronic acid
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
(Active Comparator)
hyaluronic acid combined corticosteroid injection
hyaluronic acid
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

Primary Outcomes

Measure
physical activity
time frame: 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 Outcomes

Measure
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
time frame: 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)
time frame: 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

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

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

Additional Information

Official title Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Principal investigator Ru-Lan Hsieh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Taipei Medical University.