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Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02625727
Recruitment Status : Unknown
Verified December 2015 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2015
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Shin Kong Wu Ho-Su Memorial Hospital
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
Physical Activity Other: hyaluronic acid Other: hyaluronic acid combined corticosteroid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: hyaluronic acid group
hyaluronic acid injection
Other: hyaluronic acid
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

Active Comparator: hyaluronic acid and corticosteroid group
hyaluronic acid combined corticosteroid injection
Other: hyaluronic acid combined corticosteroid
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


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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:

  • Osteoarthritis of knee with Kellgren/Lawrence grade II or III

Exclusion Criteria:

  • Who have implant in knee
  • History of neurological deficit, such as stroke

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): NCT02625727


Locations
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Taiwan
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
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Principal Investigator: Ru-Lan Hsieh, MD associate professor

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Responsible Party: Ru-Lan Hsieh, associate professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT02625727     History of Changes
Other Study ID Numbers: MOST104-2314-B-341-001
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
knee osteoarthritis
hyaluronic acid
corticosteroid
intra-articular injection
therapeutic effect
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents