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Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Genicular nerve radiofrequency neurolysis
Genicular nerve chemical neurolysis
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:

  • Coagulation disorders
  • Rheumatoid disorders
  • Infections

Sites / Locations

  • Diskapi Yildirim Beyazit Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiofrequency Neurolysis

Chemical Neurolysis

Arm Description

Radiofrequency Neurolysis of genicular nerves

Chemical Neurolysis of genicular nerves

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS)
Pain Score Change The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2022
Last Updated
July 6, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05340166
Brief Title
Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Official Title
Comparative Evaluation of the Ultrasound-guided Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Knee osteoarthritis is one of the most common causes of pain and loss of function in the elderly population and is a source of socioeconomic costs. Selective denervation of the superior medial, superior lateral and inferior medial genicular nerves, which provide the sensory innervation of the knee joint, is an effective treatment method used to relieve pain and improve functional capacity. Radiofrequency neurolysis of genicular nerves (RFN) is accepted as an effective technique for the treatment of knee pain. However, due to higher equipment costs, longer procedure times, and procedure-related pain, alternative treatments are needed.

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
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency Neurolysis
Arm Type
Active Comparator
Arm Description
Radiofrequency Neurolysis of genicular nerves
Arm Title
Chemical Neurolysis
Arm Type
Experimental
Arm Description
Chemical Neurolysis of genicular nerves
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve radiofrequency neurolysis
Intervention Description
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve chemical neurolysis
Intervention Description
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
Pain Score Change The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Time Frame
Change from baseline to 6 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: Coagulation disorders Rheumatoid disorders Infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
selin guven kose
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

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Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves

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