Clinical trial NCT06308887: Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis
Official title: Comparison of the Effectiveness of Ultrasound-Guided Perimeniscal Steroid and Dextrose Injections in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gonarthrosis
Meniscus; Degeneration
Pain, Chronic
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: At the beginning, 1.,4., 12. week
Secondary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index
timeFrame: At the beginning, 1.,4., 12. week
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Gamze Gül Güleç
Study officials:
affiliation: İstanbul Physical Medicine and Rehabilitation Hospital
name: Emre Özmen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.