Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: glucose water; Drug: hyaluronic aicd

• Registration Number: NCT03690232
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2018-09-09
• Study First Submitted QC: 2018-09-27
• Status Verified: 2018-10
• Study First Posted: 2018-10-01
• Study Start: 2018-10-08
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose group	glucose water	The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment
hyaluronic acid group	hyaluronic aicd	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.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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

Name	Time	Method
Lequesne index	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
visual analogue scale (VAS)	0,6,12 weeks	pain intensity was measured by VAS from 0 to 10

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan