The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis

January 21, 2019 updated by: Marmara University
In advanced knee osteoarthritis, postural stability is also disturbed. There are some concerns about performing radiofrequency ablation to genicular nerves since this may further decrease the postural stability of the patient. The aim of this study is to see if application of genicular radiofrequency causes a significant change in postural stability.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale
  • Knee pain more than 3 months

Exclusion Criteria:

  • Neurological diseases such as polyneuropathies
  • Presence of severe psychiatric disorders
  • Hemodynamic instability
  • History of any surgery from the knee

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Genicular RF
Patients who will receive genicular radiofrequency ablation
Procedure: radiofrequency ablation
radiofrequency ablation of the genicular nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: 3 weeks and 3 months after the intervention
The change of pain will be evaluated with 10 cm visual analogue scale will be applied to the patients, 0 being no pain while 10 being intolerable pain
3 weeks and 3 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural stability
Time Frame: 3 weeks and 3 months after the treatment
The change of weight bearing indexes of both feet will be measured
3 weeks and 3 months after the treatment
WOMAC
Time Frame: 3 weeks and 3 months after the treatment
Western Ontario & McMaster Universities Osteoarthritis Index
3 weeks and 3 months after the treatment

Collaborators and Investigators

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

Sponsor

Marmara University

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)

December 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

January 21, 2019

First Posted (ACTUAL)

January 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2018.663

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

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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