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

NCT06308887 | Completed Phase 4

• 1 other identifier: 01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis; Meniscus; Degeneration; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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 Outcomes (1)

• Western Ontario and McMaster University Osteoarthritis Index

  At the beginning, 1.,4., 12. week

Study Arms (2)

Group 1

ACTIVE COMPARATOR

patients who had perimeniscal 5 % dextrose injection

Drug: Dextrose 5% in water

Group 2

ACTIVE COMPARATOR

patients who had perimeniscal triamcinolone injection

Drug: Triamcinolone Hexacetonide

Interventions

Triamcinolone Hexacetonide DRUG

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.

Also known as: kenacort

Group 2

Dextrose 5% in water DRUG

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.

Group 1

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Gamze Gül Güleç

Kastamonu, 37150, Turkey (Türkiye)

Location

Related Publications (4)

• Di Sante L, Venditto T, Ioppolo F, Paoloni M, Mangone M, Alviti F. Ultrasound guided injection of a painful knee osteoarthritis with medial meniscus extrusion: a case series study. Muscles Ligaments Tendons J. 2017 Sep 18;7(2):331-337. doi: 10.11138/mltj/2017.7.2.331. eCollection 2017 Apr-Jun.

  PMID: 29264345 BACKGROUND

• Bayat M, Hojjati F, Boland Nazar NS, Modabberi M, Rahimi MS. Comparison of Dextrose Prolotherapy and Triamcinolone Intraarticular Injection on Pain and Function in Patients with Knee Osteoarthritis - A Randomized Clinical Trial. Anesth Pain Med. 2023 Apr 8;13(2):e134415. doi: 10.5812/aapm-134415. eCollection 2023 Apr.

  PMID: 37601963 BACKGROUND

• Robinson RL, Schnitzer TJ, Barlow S, Berry M, Bushmakin AG, Cappelleri JC, Tive L, Jackson J, Jackson J, Viktrup L. Satisfaction with Medications Prescribed for Osteoarthritis: A Cross-Sectional Survey of Patients and Their Physicians in the United States. Pain Ther. 2022 Mar;11(1):191-208. doi: 10.1007/s40122-021-00350-0. Epub 2022 Jan 13.

  PMID: 35028917 BACKGROUND

• Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646.

  PMID: 22961435 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

triamcinolone hexacetonide; Triamcinolone; Glucose; Water

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Emre Özmen, MD

  İstanbul Physical Medicine and Rehabilitation Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 13, 2024
• Study Start: October 2, 2023
• Primary Completion: February 2, 2024
• Study Completion: March 2, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)