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Clinical Trials/NCT03690232
NCT03690232
Unknown
Not Applicable

Comparison of the Clinical Efficacy of Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

Taipei Veterans General Hospital, Taiwan1 site in 1 country100 target enrollmentOctober 8, 2018

Overview

Phase
Not Applicable
Intervention
glucose water
Conditions
Osteoarthritis, Knee
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
100
Locations
1
Primary Endpoint
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Last Updated
7 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
October 8, 2018
End Date
June 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • people aged 45 years or more;
  • subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
  • 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
  • subjects with tenderness in the medial tibial plateau area

Exclusion Criteria

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

Arms & Interventions

Glucose group

The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment

Intervention: glucose water

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.

Intervention: hyaluronic aicd

Outcomes

Primary Outcomes

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 Outcomes

  • Lequesne index(0,6,12 weeks)
  • visual analogue scale (VAS)(0,6,12 weeks)

Study Sites (1)

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