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

NCT ID: NCT06308887

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-03-02

Brief Summary

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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.

Detailed Description

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Conditions

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Gonarthrosis Meniscus; Degeneration Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

patients who had perimeniscal 5 % dextrose injection

Group Type ACTIVE_COMPARATOR

Dextrose 5% in water

Intervention Type 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 2

patients who had perimeniscal triamcinolone injection

Group Type ACTIVE_COMPARATOR

Triamcinolone Hexacetonide

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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kenacort

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kastamonu University

OTHER

Sponsor Role lead

Responsible Party

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Gamze Gul Gulec

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emre Özmen, MD

Role: STUDY_CHAIR

İstanbul Physical Medicine and Rehabilitation Hospital

Locations

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Gamze Gül Güleç

Kastamonu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29264345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37601963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35028917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22961435 (View on PubMed)

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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