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

NCT07102225 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 5506
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  VAS consisting of a 100mm long horizontal line, where 0 at one end indicates no pain and 100 at another end indicates worst pain. Number of participants will be assessed from baseline in pain scores on the Visual Analog Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.

  Outcome 1: " VAS score at week 1", Outcome 2: "VAS score at week 4", Outcome 3: "VAS score at week 12",

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  WOMAC is a questionnaire consisting of 24 items organized into 3 subscales like pain, stiffness and physical function that is used in patients with knee osteoarthritis. Total score ranges from 0 to 96, with higher scores indicating worse symptoms. Number of participants will be assessed from baseline on the WOMAC Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.

  Outcome 1: " WOMAC score at week 1", Outcome 2: " WOMAC score at week 4", Outcome 3: " WOMAC score at week 12"

Study Arms (1)

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

EXPERIMENTAL

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

Drug: prolotherapy solution of 20% dextrose; Drug: Hyaluronic Acid (HA)

Interventions

prolotherapy solution of 20% dextrose 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.

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

Hyaluronic Acid (HA) 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.

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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

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

Dhaka, Shahbag, 1000, Bangladesh

Location

MeSH Terms

Interventions

Glucose; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Glycosaminoglycans; Polysaccharides

Study Officials

• Farzana Khan Shoma, MBBS, FCPS

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 3, 2025
• Study Start: May 4, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

BA (1)