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Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intra-articular Pulsed Radiofrequency
Steroid Injection
Sponsored by
Basaksehir Cam & Sakura Şehir Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring intra-articular pulsed radiofrequency, knee osteoarthritis, intra-articular steroid injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Başakşehir Cam and Sakura Şehir Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Intra-articular Pulsed Radiofrequency and Steroid Injection

Only Intra-articular Steroid Injection

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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.

Full Information

First Posted
August 24, 2023
Last Updated
August 24, 2023
Sponsor
Basaksehir Cam & Sakura Şehir Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06017674
Brief Title
Intra-articular Pulsed Radiofrequency in Chronic Knee Pain
Official Title
The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basaksehir Cam & Sakura Şehir Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic
Keywords
intra-articular pulsed radiofrequency, knee osteoarthritis, intra-articular steroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, single-blinded, randomized prospective trial
Masking
Investigator
Masking Description
Procedures and evaluations were performed by different practitioners
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Intra-articular Pulsed Radiofrequency and Steroid Injection
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Only Intra-articular Steroid Injection
Intervention Type
Procedure
Intervention Name(s)
Intra-articular Pulsed Radiofrequency
Intervention Description
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
Drug
Intervention Name(s)
Steroid Injection
Intervention Description
8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Description
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."
Time Frame
0, 1, 4 and 12 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Arthritis Index
Description
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.
Time Frame
0, 1, 4 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Erken, MD
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Başakşehir Cam and Sakura Şehir Hospital
City
Istanbul
ZIP/Postal Code
34488
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34518775
Citation
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.
Results Reference
result
PubMed Identifier
23942592
Citation
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.
Results Reference
result
PubMed Identifier
21872812
Citation
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.
Results Reference
result
PubMed Identifier
18211593
Citation
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.
Results Reference
result

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Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

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