Clinical trial

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

Name

2022.03.89

Description

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.

Trial arms

Trial start

2022-05-01

Estimated PCD

2022-09-30

Trial end

2022-12-31

Status

Completed

Treatment

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.

Arms:

Group 1

Steroid Injection

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

Arms:

Group 1, Group 2

Size

Primary endpoint

Numeric Rating Scale

0, 1, 4 and 12 weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, single-blinded, randomized prospective trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Procedures and evaluations were performed by different practitioners', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

Updated at

2023-08-30

1 organization

1 product

4 indications

Organization

Başakşehir Çam & Sakura City Hospital

Product

Indication

Indication

Indication

Indication