Effects of Intra-articular Hypertonic D… | Clinical Trial

Key information

Conditions

Mild to Moderate Knee OA

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Dhaka, Shahbag, 1000, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

Visual Analog Scale (VAS)

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

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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

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.

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis: A Randomized Control Trial

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 3, 2025
Registry last updated: Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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