Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690232
• Other study ID #: 2018-01-014C
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jia chi Wang, MD
• Phone: 886-2-28757361
• Email: jcwang0726[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• glucose water
3 sessions of 6cc 25% glucose injection with a 2-week interval
• 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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	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	0,6,12 weeks
Secondary	visual analogue scale (VAS)	pain intensity was measured by VAS from 0 to 10	0,6,12 weeks