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Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

glucose water

hyaluronic aicd

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glucose group

hyaluronic acid group

Arm 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 Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment.

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

Lequesne index

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

visual analogue scale (VAS)

pain intensity was measured by VAS from 0 to 10

Full Information

NCT ID

NCT03690232

First Posted

September 9, 2018

Last Updated

October 9, 2018

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03690232

Brief Title

Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 8, 2018 (Actual)

Primary Completion Date

June 1, 2020 (Anticipated)

Study Completion Date

June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

outcomes assessor and participant do not know the treatment patient received.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Glucose group

Arm Type

Experimental

Arm Description

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

Arm Title

hyaluronic acid group

Arm Type

Active Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

glucose water

Intervention Description

3 sessions of 6cc 25% glucose injection with a 2-week interval

Intervention Type

Drug

Intervention Name(s)

hyaluronic aicd

Other Intervention Name(s)

Hyruan

Intervention Description

intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment

Primary Outcome Measure Information:

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Lequesne index

Description

Time Frame

0,6,12 weeks

Title

visual analogue scale (VAS)

Description

pain intensity was measured by VAS from 0 to 10

Time Frame

0,6,12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jia chi Wang, MD

Phone

886-2-28757361

jcwang0726@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia chi Wang, MD

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Study Director

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

241

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jia chi c Wang, MD

Phone

886-2-28757361

jcwang0726@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

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