Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves

July 6, 2023 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital

Comparative Evaluation of the Ultrasound-guided Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Diskapi Yildirim Beyazit Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • Coagulation disorders
  • Rheumatoid disorders
  • Infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiofrequency Neurolysis
Radiofrequency Neurolysis of genicular nerves
Procedure: Genicular nerve radiofrequency neurolysis
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Experimental: Chemical Neurolysis
Chemical Neurolysis of genicular nerves
Procedure: Genicular nerve chemical neurolysis
Neurolysis of superomedial, superolateral and inferomedial genicular nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS)
Time Frame: Change from baseline to 6 months after procedure
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.
Change from baseline to 6 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: selin guven kose, Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2022

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131/01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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