Parallel Versus Perpendicular Technique for Genicular Radiofrequency

Parallel Versus Perpendicular Technique for Genicular Radiofrequency Ablation

Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Perpendicular Group; Procedure: Parallel Group

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Yenimahalle, Ankara, Turkey, 06170
      • Recruiting
      • Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

• Intra-articular injections in the knee during the 3 months prior to procedure
• Chronic pain syndrome
• Lumbar radicular pain
• Patients who are unwilling or mentally incapable to complete the study questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perpendicular Group; Perpendicular genicular radiofrequency application	Procedure: Perpendicular Group; Radiofrequency ablation was applied to the perpendicular group by placing the tip of electrode perpendicularly to contact the genicular nerves.
Active Comparator: Parallel Group; Parallel genicular radiofrequency application	Procedure: Parallel Group; Radiofrequency ablation was applied to the parallel group by placing the electrode lay parallel to contact the genicular nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)	The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (0-10).The lower the score, the least pain the patient experiences.	6 months after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	WOMAC is a 24-item scale under the headings of pain, stiffness and functional activity. Patients rate the amount of strain, pain felt, and joint stiffness during daily activities between 0 and 4 (0 is the best, 4 is the worst), and the total score is between 0 and 96.	6 months after intervention.

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): September 15, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 139/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No