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Parallel Versus Perpendicular Technique for Genicular Radiofrequency

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Perpendicular Group
Parallel Group
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Health Science University Diskapi Yildirim Beyazıt Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Perpendicular Group

Parallel Group

Arm Description

Perpendicular genicular radiofrequency application

Parallel genicular radiofrequency application

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 1, 2022
Last Updated
April 2, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05528965
Brief Title
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
Official Title
Parallel Versus Perpendicular Technique for Genicular Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perpendicular Group
Arm Type
Experimental
Arm Description
Perpendicular genicular radiofrequency application
Arm Title
Parallel Group
Arm Type
Active Comparator
Arm Description
Parallel genicular radiofrequency application
Intervention Type
Procedure
Intervention Name(s)
Perpendicular Group
Intervention Description
Radiofrequency ablation was applied to the perpendicular group by placing the tip of electrode perpendicularly to contact the genicular nerves.
Intervention Type
Procedure
Intervention Name(s)
Parallel Group
Intervention Description
Radiofrequency ablation was applied to the parallel group by placing the electrode lay parallel to contact the genicular nerves.
Primary Outcome Measure Information:
Title
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)
Description
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.
Time Frame
6 months after intervention.
Secondary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
6 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
City
Yenimahalle
State/Province
Ankara
ZIP/Postal Code
06170
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halil C Kose, MD
Phone
+90505 762 86 82
Email
halilcihankose@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Parallel Versus Perpendicular Technique for Genicular Radiofrequency

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