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Clinical Trials/NCT06308887
NCT06308887
Completed
Phase 4

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

Kastamonu University1 site in 1 country31 target enrollmentOctober 2, 2023

Overview

Phase
Phase 4
Intervention
Dextrose 5% in water
Conditions
Gonarthrosis
Sponsor
Kastamonu University
Enrollment
31
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2023
End Date
March 2, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gamze Gul Gulec

Doctor

Kastamonu University

Eligibility Criteria

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

Arms & Interventions

Group 1

patients who had perimeniscal 5 % dextrose injection

Intervention: Dextrose 5% in water

Group 2

patients who had perimeniscal triamcinolone injection

Intervention: Triamcinolone Hexacetonide

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Western Ontario and McMaster University Osteoarthritis Index(At the beginning, 1.,4., 12. week)

Study Sites (1)

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