Back to resultsAdditional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis
Primary Purpose
Physical Activity, Functional Performance
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Triamcinolone
Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Physical Activity focused on measuring knee osteoarthritis, triamcinolone, therapeutic effects
Eligibility Criteria
Inclusion Criteria:
- knee osteoarthritis with Kellgren/Lawrence grade II or III
Exclusion Criteria:
- who have neurological deficit, such as stroke who have implant in knee
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
triamcinolone and hyaluronic acid group
hyaluronic acid group
Arm Description
combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
hyaluronic acid (2cc) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
Outcomes
Primary Outcome Measures
Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index
Western Ontario and McMaster Universities Osteoarthritis Index
Secondary Outcome Measures
10 meter walk test
10 meter walk as fast as possible
Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score
5 times rapid chair rising test
rapid chair rising for 5 times as fast as possible
Full Information
NCT ID
NCT02949466
First Posted
October 25, 2016
Last Updated
October 29, 2016
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02949466
Brief Title
Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis
Official Title
Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.
Detailed Description
A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.
The triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks.
Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Functional Performance
Keywords
knee osteoarthritis, triamcinolone, therapeutic effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
triamcinolone and hyaluronic acid group
Arm Type
Experimental
Arm Description
combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
Arm Title
hyaluronic acid group
Arm Type
Active Comparator
Arm Description
hyaluronic acid (2cc) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
corticosteroids
Intervention Description
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Intervention Description
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis
Primary Outcome Measure Information:
Title
Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
changes from baseline to at after one week, one month, three months, and six months of completion of injections
Secondary Outcome Measure Information:
Title
10 meter walk test
Description
10 meter walk as fast as possible
Time Frame
changes from baseline to at after one week, one month, three months, and six months of completion of injections
Title
Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score
Description
Knee Injury and Osteoarthritis Outcome Score
Time Frame
changes from baseline to at after one week, one month, three months, and six months of completion of injections
Title
5 times rapid chair rising test
Description
rapid chair rising for 5 times as fast as possible
Time Frame
changes from baseline to at after one week, one month, three months, and six months of completion of injections
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:
knee osteoarthritis with Kellgren/Lawrence grade II or III
Exclusion Criteria:
who have neurological deficit, such as stroke who have implant in knee
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2538;2531
Email
M001052@ms.skh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2538;2531
Email
rulan@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
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
Plan to Share IPD
No
Citations:
PubMed Identifier
34958762
Citation
Wang CP, Lee WC, Hsieh RL. Effects of Repeated Co-Injections of Corticosteroids and Hyaluronic Acid on Knee Osteoarthritis: A Prospective, Double-Blind Randomized Controlled Trial. Am J Med. 2022 May;135(5):641-649. doi: 10.1016/j.amjmed.2021.11.016. Epub 2021 Dec 24.
Results Reference
derived
Learn more about this trial
Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis
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