Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

NCT06017674 | Completed

• 1 other identifier: 2022.03.89
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain, Chronic

Keywords

intra-articular pulsed radiofrequency; knee osteoarthritis; intra-articular steroid injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Western Ontario and McMaster Universities Arthritis Index

  0, 1, 4 and 12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Intra-articular Pulsed Radiofrequency and Steroid Injection

Procedure: Intra-articular Pulsed Radiofrequency; Drug: Steroid Injection

Group 2

EXPERIMENTAL

Only Intra-articular Steroid Injection

Drug: Steroid Injection

Interventions

Intra-articular Pulsed Radiofrequency 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.

Group 1

Steroid Injection DRUG

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Cam and Sakura Şehir Hospital

Istanbul, 34488, Turkey (Türkiye)

Location

Related 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 Safety. Pain Res Manag. 2021 Feb 20;2021:5554631. doi: 10.1155/2021/5554631. eCollection 2021.

  PMID: 34518775 RESULT

• 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.

  PMID: 23942592 RESULT

• 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.

  PMID: 21872812 RESULT

• 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.

  PMID: 18211593 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Chronic Pain

Interventions

Steroids

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Burak Erken, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Procedures and evaluations were performed by different practitioners
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Single-center, single-blinded, randomized prospective trial

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)