Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis.

NCT ID: NCT07102225

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-04
• Study Completion Date: 2026-09-30

Brief Summary

The aim of this study is to compare the effectiveness of intra-articular hypertonic dextrose and hyaluronic acid in managing pain and improving function in patients with primary knee osteoarthritis (KOA). This study will guide us to treat primary KOA patients with dextrose prolotherapy instead of hyaluronic acid more effectively.

Conditions

Mild to Moderate Knee OA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis

To see the effectiveness of intra-articular hypertonic dextrose versus hyaluronic acid on primary knee OA

Group Type: EXPERIMENTAL

prolotherapy solution of 20% dextrose

Intervention Type: DRUG

This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint.

Hyaluronic Acid (HA)

Intervention Type: DRUG

This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint.

Interventions

prolotherapy solution of 20% dextrose

This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint.

Intervention Type: DRUG

Hyaluronic Acid (HA)

This intervention is open label. Both participants and investigator will know about the intervention. Participants are allocated according to simple randomization by lottery. Two groups with each contain 28 participants. One group will be given a mixture of intra-articular injection of 5.6 ml 25% dextrose and 1.4 ml 2% lignocaine to achieve a final concentration 20% dextrose with 0.4% lignocaine in the involved knee joint. Another group will be given 1.4 ml 2% lignocaine followed by 2 ml high molecular weight hyaluronic acid intra-articularly in the involved joint.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Knee OA diagnosis satisfying the American College of Rheumatology clinical and radiographic criteria, Kellgren-Lawrence grade of II and III determined by Postero-anterior knee radiograph.
• Participants will have the ability to undergo 3 months of follow-up
• Participants who will agree to avoid non-steroidal anti-inflammatory drugs during the research (acetaminophen will be prescribed for intractable pain)

Exclusion Criteria

• Participants who will give a self-reported history of knee surgery, fracture, or infection.
• Kellgren-Lawrence grade IV KOA.
• Participants on anticoagulants.
• Participants who will have previous history of intra-articular knee injection of HA or prolotherapy within 6 months.
• Participants who have malignant disease or secondary KOA.
• Participants who will have a history of comorbid illness(es) like chronic heart failure, advanced COPD, end-stage renal failure, advanced liver disease and poorly controlled DM.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangladesh Medical University

OTHER

Sponsor Role: lead

Responsible Party

Raju Dey

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farzana Khan Shoma, MBBS, FCPS

Role: STUDY_DIRECTOR

Bangladesh Medical University (formerly known as Bangabandhu Sheikh Mujib Medical University)

Locations

Bangladesh Medical University (formerly known as Bangabandhu Sheikh Mujib Medical University)

Dhaka, Shahbag, Bangladesh

Countries

Bangladesh

Other Identifiers

5506

Identifier Type: -

Identifier Source: org_study_id