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Effects of Dextrose on Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03238183
Recruitment Status : Unknown
Verified August 2017 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

Study Description
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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 dextrose injection to patients with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Physical Activity Functional Disturbance Drug: dextrose Device: hyaluronic acid Phase 4

Detailed Description:

A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.

The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks.

The pain, physical activity, and functional performance will be evaluated.

All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six month after injection.

Subjects and the evaluator will be both blinded to the group's classification during the whole course of study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: hyaluronic acid combined dextrose group
Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
 Drug: dextrose
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
Other Name: glucose water

Device: hyaluronic acid
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
Placebo Comparator: hyaluronic acid group
Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
 Device: hyaluronic acid
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis


Outcome Measures
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Primary Outcome Measures :
  1. physical activity-on level walking time [ Time Frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection ]
    10 meter walking

  2. physical activity-stair climbing time [ Time Frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection ]
    stairs climbing

  3. physical activity-chair rising time [ Time Frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection ]
    chair rising


Secondary Outcome Measures :
  1. functional performance [ Time Frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection ]
    Western Ontario and McMaster Universities Osteoarthritis index

  2. quality of life [ Time Frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection ]
    Knee Injury and Osteoarthritis Outcome Score


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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): NCT03238183


Contacts
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Contact: Ru-Lan Hsieh 228332211 M001052@ms.skh.org.tw
Contact: Ru-Lan Hsieh 228332211 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 Shin Kong Wu Ho-Su Memorial Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ru-Lan Hsieh, Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03238183    
Other Study ID Numbers: MOST 106-2314-B-341-003
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
knee osteoarthritis
hyaluronic acid
dextrose
therapeutic effects
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