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Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690232
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: glucose water Drug: hyaluronic aicd Not Applicable

Detailed Description:
The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment. The HA group was administered intra-articular HA ((Hyruan PlusR, average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. The results were measured with the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. A baseline for each test was measured before treatment and then the effects of the treatments were measured by each test at 6 and 12 weeks after treatment

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study in the first year is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: outcomes assessor and participant do not know the treatment patient received.
Primary Purpose: Treatment
Official Title: Comparison of the Clinical Efficacy of Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Glucose group
The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment
Drug: glucose water
3 sessions of 6cc 25% glucose injection with a 2-week interval

Active Comparator: hyaluronic acid group
The HA group was administered intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment.
Drug: hyaluronic aicd
intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment
Other Name: Hyruan




Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 12 weeks ]
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales


Secondary Outcome Measures :
  1. Lequesne index [ Time Frame: 0,6,12 weeks ]
    The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living

  2. visual analogue scale (VAS) [ Time Frame: 0,6,12 weeks ]
    pain intensity was measured by VAS from 0 to 10



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. people aged 45 years or more;
  2. subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
  3. subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
  4. subjects with tenderness in the medial tibial plateau area

Exclusion Criteria:

  1. . subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;
  2. . Inflammatory arthritis or subjects with acute knee arthritis
  3. . subjects who have received intraarticular injection on the affected knee within the past 3 months.
  4. . subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.

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): NCT03690232


Contacts
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Contact: Jia chi Wang, MD 886-2-28757361 jcwang0726@gmail.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 241
Contact: Jia chi c Wang, MD    886-2-28757361    jcwang0726@gmail.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Director: Jia chi Wang, MD Taipei Veterans General Hospital, Taiwan
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03690232    
Other Study ID Numbers: 2018-01-014C
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases