Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis

March 11, 2024 updated by: Gamze Gul Gulec, Kastamonu University

Comparison of the Effectiveness of Ultrasound-Guided Perimeniscal Steroid and Dextrose Injections in Knee Osteoarthritis

Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.

Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kastamonu, Turkey, 37150
        • Gamze Gül Güleç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Grade 2-4 knee osteoarthritis,
  • Aged 40 to 79
  • Chronic medial knee pain persisting for more than 3 months.
  • Ultrasound screening found medial meniscal extrusion of more than 3 mm
  • A Visual Analog Scale (VAS) score of at least 4.

Exclusion Criteria:

a skin infection at the injection site, a prior history of inflammatory arthropathy, a prior history of knee injection within the last 3 months, knee synovitis pes anserine bursitis scheduled for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
patients who had perimeniscal 5 % dextrose injection
Drug: Dextrose 5% in water
Ultrasound-guided periarticular (perimeniscal) injection: The injections were administered using ultrasonic guidance on the longitudinal axis while the patient was in a supine position with the knee flexed at approximately 20°-30°. The transducer was positioned longitudinally in the region where extrusion was seen along the medial collateral ligament. Subsequently, employing a free-hand method, a 0.60x60 mm 23 G needle was inserted directly into the meniscus wall with the use of sonographic guidance. After the needle made contact with the medial meniscus wall, it was pulled back by 1 mm and placed between the medial collateral ligament and the medial meniscus, and a dose of 5 ml of 5% dextrose was injected.
Active Comparator: Group 2
patients who had perimeniscal triamcinolone injection
Drug: Triamcinolone Hexacetonide
Ultrasound-guided periarticular (perimeniscal) injection: The injections were administered using ultrasonic guidance on the longitudinal axis while the patient was in a supine position with the knee flexed at approximately 20°-30°. The transducer was positioned longitudinally in the region where extrusion was seen along the medial collateral ligament. Subsequently, employing a free-hand method, a 0.60x60 mm 23 G needle was inserted directly into the meniscus wall with the use of sonographic guidance. After the needle made contact with the medial meniscus wall, it was pulled back by 1 mm and placed between the medial collateral ligament and the medial meniscus, and a dose of 0.5 mg/5 ml of triamcinolone acetonide was injected.
Other Names:
  • kenacort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: At the beginning, 1.,4., 12. week
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients with similar conditions.VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line.
At the beginning, 1.,4., 12. week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster University Osteoarthritis Index
Time Frame: At the beginning, 1.,4., 12. week
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: pain, stiffness, and physical function. The test questions are scored on a scale of 0-4, which corresponds to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Usually, a sum of the scores for all three subscales gives a total WOMAC score, and higher scores mean a worse outcome.
At the beginning, 1.,4., 12. week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kastamonu University

Investigators

  • Study Chair: Emre Özmen, MD, İstanbul Physical Medicine and Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

March 2, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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