Effects of Knee Injections on Patients With Knee Osteoarthritis

January 20, 2022 updated by: Taipei Medical University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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:

  1. clinical diagnosis of knee osteoarthritis
  2. can walk for 15 meters
  3. Kellgren-Lawrence grade 2 or greater
  4. can follow up for 6 months

Exclusion Criteria:

  1. Major diseases will affect balance, such as stroke
  2. infectious disease,
  3. rheumatoid arthritis,
  4. malignancy
  5. pregnancy or prepare to pregnant
  6. received knee injections in the past 6 months
  7. previous knee operation history

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
triamcinolone plus hyruan injection
Drug: Triamcinolone plus hyruan
triamcinolone plus hyruan injections, one time per week, for 3 weeks
Other Names:
  • corticosteroids plus hyaluronic acid
Active Comparator: Experimental
vitagen plus hyruan injection
Drug: vitagen plus hyruan
vitagen plus hyruan injections, one time per week, for 3 weeks
Other Names:
  • dextrose plus hyaluronic acid
Placebo Comparator: Placebo
normal saline plus hyruan injection
Drug: normal saline plus hyruan
normal saline plus hyruan injections, one time per week, for 3 weeks
Other Names:
  • normal saline plus hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis index
Time Frame: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
assess knee related performance, scores: 0-100, higher score indicates a worse outcome
changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical functional performance-walking
Time Frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
10 meters normal and fast walking speed
changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-stairs climbing
Time Frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
time for up and down stairs
changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-chair rising
Time Frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
time for 5 repeated chair-rising time
changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
physical functional performance-balance
Time Frame: changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
time for up and go test
changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
Knee Injury and Osteoarthritis Outcome Score
Time Frame: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
assess knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome
changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

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

  • Study Chair: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

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 (Actual)

August 1, 2020

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOST109-2314-B-341-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

By request, the data will be shared with other researchers.

IPD Sharing Time Frame

The data will become available after publication and for one year since publication.

IPD Sharing Access Criteria

Request by mail to the investigator.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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