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Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02949466
Recruitment Status : Unknown
Verified October 2016 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
Physical Activity Functional Performance Drug: Triamcinolone Device: Hyaluronic acid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: triamcinolone and hyaluronic acid group
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
Drug: Triamcinolone
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis
Other Name: corticosteroids

Device: Hyaluronic acid
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis

Active Comparator: hyaluronic acid group
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
Device: Hyaluronic acid
compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis




Primary Outcome Measures :
  1. Functional performance assessed with the 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 ]
    Western Ontario and McMaster Universities Osteoarthritis Index


Secondary Outcome Measures :
  1. 10 meter walk test [ Time Frame: changes from baseline to at after one week, one month, three months, and six months of completion of injections ]
    10 meter walk as fast as possible

  2. Quality of life assessed with the 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 ]
    Knee Injury and Osteoarthritis Outcome Score

  3. 5 times rapid chair rising test [ Time Frame: changes from baseline to at after one week, one month, three months, and six months of completion of injections ]
    rapid chair rising for 5 times as fast as possible



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949466


Contacts
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Contact: Ru-Lan Hsieh, MD 886-2-28332211 ext 2538;2531 M001052@ms.skh.org.tw
Contact: Ru-Lan Hsieh, MD 886-2-28332211 ext 2538;2531 rulan@tmu.edu.tw

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Sponsors and Collaborators
Taipei Medical University
Investigators
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Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital

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Responsible Party: Ru-Lan Hsieh, Associate Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT02949466     History of Changes
Other Study ID Numbers: MOST 105-2314-B-341-002
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
knee osteoarthritis
triamcinolone
therapeutic effects
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Hyaluronic Acid
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Viscosupplements
Protective Agents