Clinical trial NCT06017674: Intra-articular Pulsed Radiofrequency in Chronic Knee Pain
Official title: The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis
Pain, Chronic
Keywords: intra-articular pulsed radiofrequency
knee osteoarthritis
intra-articular steroid injection
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, single-blinded, randomized prospective trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis.

Detailed description: This randomized controlled trial included patients over 18 years of age with knee pain persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group 1) and only steroid injection (Group 2) groups. The injections were administered under fluoroscopic guidance in both groups, and the needle was advanced to the midline of the tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only. Pain intensity and participation in daily activities were evaluated using the numerical rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC), respectively, before the procedure and 1, 4, and 12 weeks after the procedure.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA),
* Kellgren-Lawrence Classification grades II and III OA,
* Giving written and verbal informed consents.

Exclusion Criteria:

* Patients with a history of undergoing knee surgery and/or receiving any intra-articular knee injection within the previous 6 months,
* Having a local or systemic infection or a coagulation disorder,
* Patients who refused to participate in the study.

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: 0, 1, 4 and 12 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 0, 1, 4 and 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Cam and Sakura Şehir Hospital
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Burak Erken, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Filippiadis D, Tsochatzis A, Petsatodis E, Galanis S, Velonakis G, Giankoulof C, Kelekis A. Intra-Articular Application of Sluijter-Teixera Poisson Pulsed Radiofrequency in Symptomatic Patients with Knee Osteoarthritis: Focus upon Clinical Efficacy and Safety. Pain Res Manag. 2021 Feb 20;2021:5554631. doi: 10.1155/2021/5554631. eCollection 2021.
citation: Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
citation: Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
citation: Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.