Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

Not Applicable

Completed

• Conditions: Pain, Chronic; Osteoarthritis, Knee; Osteoarthritis
• Interventions: Procedure: Intra-articular Pulsed Radiofrequency; Drug: Steroid Injection

• Registration Number: NCT06017674
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Steroid Injection	Intra-articular Pulsed Radiofrequency and Steroid Injection
Group 1	Intra-articular Pulsed Radiofrequency	Intra-articular Pulsed Radiofrequency and Steroid Injection
Group 2	Steroid Injection	Only Intra-articular Steroid Injection

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	0, 1, 4 and 12 weeks	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."

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Arthritis Index	0, 1, 4 and 12 weeks	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.

Trial Locations

Locations (1)

Başakşehir Cam and Sakura Şehir Hospital; 🇹🇷 Istanbul, Turkey