Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

Sponsor

Basaksehir Cam & Sakura Şehir Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06017674

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Osteoarthritis Pain, Chronic	Procedure: Intra-articular Pulsed Radiofrequency Drug: Steroid Injection	N/A

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

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-center, single-blinded, randomized prospective trialSingle-center, single-blinded, randomized prospective trial

Masking:

Single (Investigator)

Masking Description:

Procedures and evaluations were performed by different practitioners

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Group 1

Intra-articular Pulsed Radiofrequency and Steroid Injection

Procedure: 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.

Drug: Steroid Injection

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

Experimental: Group 2

Only Intra-articular Steroid Injection

Drug: Steroid Injection

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Başakşehir Cam and Sakura Şehir Hospital	Istanbul		Turkey	34488

Sponsors and Collaborators

Basaksehir Cam & Sakura Şehir Hospital

Investigators

Principal Investigator: Burak Erken, MD, Basaksehir Cam & Sakura Şehir Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Burak Erken, Medical Doctor, Basaksehir Cam & Sakura Şehir Hospital

ClinicalTrials.gov Identifier:

NCT06017674

Other Study ID Numbers:

2022.03.89

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Burak Erken, Medical Doctor, Basaksehir Cam & Sakura Şehir Hospital

intra-articular pulsed radiofrequency

knee osteoarthritis

intra-articular steroid injection

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Chronic Pain

Study Results

No Results Posted as of Aug 30, 2023