Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

NCT ID: NCT03690232

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2020-06-01

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

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Glucose group

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

Group Type: EXPERIMENTAL

glucose water

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

hyaluronic aicd

Intervention Type: DRUG

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

Interventions

glucose water

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Hyruan

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia chi Wang, MD

Role: STUDY_DIRECTOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jia chi Wang, MD

Role: CONTACT

jcwang0726@gmail.com

886-2-28757361

Facility Contacts

Jia chi c Wang, MD

Role: primary

jcwang0726@gmail.com

886-2-28757361

Other Identifiers

2018-01-014C

Identifier Type: -

Identifier Source: org_study_id