Back to resultsEffects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis
Primary Purpose
Physical Activity
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
hyaluronic acid
hyaluronic acid combined corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Physical Activity focused on measuring knee osteoarthritis, hyaluronic acid, corticosteroid, intra-articular injection, therapeutic effect
Eligibility Criteria
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
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hyaluronic acid group
hyaluronic acid and corticosteroid group
Arm Description
hyaluronic acid injection
hyaluronic acid combined corticosteroid injection
Outcomes
Primary Outcome Measures
physical activity
Secondary Outcome Measures
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
functional performance (Knee injury and Osteoarthritis Outcome Score)
Full Information
NCT ID
NCT02625727
First Posted
December 1, 2015
Last Updated
December 8, 2015
Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02625727
Brief Title
Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis
Official Title
Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity
Keywords
knee osteoarthritis, hyaluronic acid, corticosteroid, intra-articular injection, therapeutic effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyaluronic acid group
Arm Type
Experimental
Arm Description
hyaluronic acid injection
Arm Title
hyaluronic acid and corticosteroid group
Arm Type
Active Comparator
Arm Description
hyaluronic acid combined corticosteroid injection
Intervention Type
Other
Intervention Name(s)
hyaluronic acid
Intervention Description
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
Intervention Type
Other
Intervention Name(s)
hyaluronic acid combined corticosteroid
Intervention Description
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis
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