Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

Osteoarthritis Clinical Trial

Official title:

The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06017674
• Other study ID #: 2022.03.89
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Chronic

Intervention

Procedure:
• Intra-articular Pulsed Radiofrequency
A 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C.

Drug:
• Steroid Injection
8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.

Locations

Country	Name	City	State
Turkey	Basaksehir Cam and Sakura Sehir Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 Sa — View 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. Ep — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale	Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where "0" represents "no pain at all" and "10" represents "worst pain ever possible."	0, 1, 4 and 12 weeks
Secondary	Western Ontario and McMaster Universities Arthritis Index	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to assess daily living activities at all evaluation points.The WOMAC consists of 24 items on three subscales: pain, stiffness, and physical function. All items were scored on a scale of 0 to 4, where "0" represents none, "1" represents mild, "2" represents moderate, "3" represents severe, and "4" represents extreme. The total score ranges from 0 to 96, with a higher score indicating poorer function in daily living activities.	0, 1, 4 and 12 weeks