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Effects of Knee Injections on Patients With Knee Osteoarthritis

Sponsor
Taipei Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05220527
Collaborator
Shin Kong Wu Ho-Su Memorial Hospital (Other)
60
Enrollment
1
Location
3
Arms
24
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Triamcinolone plus hyruan
  • Drug: vitagen plus hyruan
  • Drug: normal saline plus hyruan
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Western Ontario and McMaster Universities Osteoarthritis index [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

    Secondary Outcome Measures

    1. physical functional performance-walking [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

    2. physical functional performance-stairs climbing [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

    3. physical functional performance-chair rising [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

    4. physical functional performance-balance [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

    5. Knee Injury and Osteoarthritis Outcome Score [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan 111-01

    Sponsors and Collaborators

    • Taipei Medical University
    • Shin Kong Wu Ho-Su Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT05220527
    Other Study ID Numbers:
    • MOST109-2314-B-341-001
    First Posted:
    Feb 2, 2022
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Taipei Medical University
    knee osteoarthritis
    steroid
    hyaluronic acid
    dextrose
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Triamcinolone
    Hyaluronic Acid

    Study Results

    No Results Posted as of Feb 2, 2022