Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

NCT ID: NCT06017674

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-31

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Intra-articular Pulsed Radiofrequency and Steroid Injection

Group Type: EXPERIMENTAL

Intra-articular Pulsed Radiofrequency

Intervention Type: PROCEDURE

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.

Steroid Injection

Intervention Type: DRUG

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

Group 2

Only Intra-articular Steroid Injection

Group Type: EXPERIMENTAL

Steroid Injection

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Steroid Injection

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Burak Erken

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burak Erken, MD

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

Başakşehir Cam and Sakura Şehir Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 34518775 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23942592 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21872812 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18211593 (View on PubMed)

Other Identifiers

2022.03.89

Identifier Type: -

Identifier Source: org_study_id