Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis

December 8, 2015 updated by: Ru-Lan Hsieh, Taipei Medical University

Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hyaluronic acid group
hyaluronic acid injection
Other: 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 and corticosteroid group
hyaluronic acid combined corticosteroid injection
Other: hyaluronic acid combined corticosteroid
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Collaborators

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Principal Investigator: Ru-Lan Hsieh, MD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOST104-2314-B-341-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on hyaluronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe