Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic

Intervention / Treatment
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* Procedure: Intra-articular Pulsed Radiofrequency
* Drug: Steroid Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, single-blinded, randomized prospective trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Intra-articular Pulsed Radiofrequency and Steroid Injection | Procedure: Intra-articular Pulsed Radiofrequency<br>* 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.<br>Drug: Steroid Injection<br>* 8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.<br>|
| Experimental: Group 2<br>Only Intra-articular Steroid Injection | Drug: Steroid Injection<br>* 8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-articular pulsed radiofrequency, knee osteoarthritis, intra-articular steroid injection