Ultrasound-guided Radiofrequency Ablation of the Genicular Nerve Versus Physical Therapy for Chronic Knee Osteoarthritis

December 14, 2023 updated by: Merve Çakır, Ankara City Hospital Bilkent

Comparison of the Effectiveness of Physical Therapy With Ultrasound-Guided Radiofrequency Ablation of the Genicular Nerve in Patients With Chronic Knee Osteoarthritis

The aim of this study is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with Chronic Knee Osteoarthritis according to the American College of Rheumatology criteria, and with radiological osteoarthritis at Kellgren-Lawrence grades 2 and 3, within the age range of 45-70, and meeting the study criteria will be included in the study. After providing information about the procedures to be performed and potential risks to the patients, if they give their written informed consent, treatment methods will be applied to the patients. Eligible patients will be divided into two groups. In one group, Radiofrequency Ablation of the Genicular Nerve under Ultrasound Guidance will be performed, while the other group will receive physical therapy.

Study Type

Interventional

Enrollment (Estimated)

68

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 Contact

  • Name: Fatma Gül Yurdakul, Associate Professor (medical)
  • Phone Number: +905059254214
  • Email: fatmagulonder@gmail.com

Study Locations

  • Turkey
    • Bilkent - Çankaya
      • Ankara, Bilkent - Çankaya, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • VAS ≥ 5
  • To be aged between 45 and 70 years old
  • Patients diagnosed with chronic knee osteoarthritis using the American College of Rheumatology criteria and having radiological osteoarthritis of Kellgren-Lawrence grade 2 and 3
  • Cognitive functions being intact
  • Being willing to participate in the study and signing the consent forms

Exclusion Criteria:

  • Having received physical therapy for chronic knee osteoarthritis in the last 6 months
  • Having received glucocorticoid or hyaluronic acid injections in the last 6 months
  • Having taken oral glucosamine
  • Undergoing knee surgery
  • Having current neurological or mental disorders
  • History of pacemaker usage
  • Presence of local infections or sepsis
  • Progressive neurological deficit
  • Presence of oncological diseases
  • Hemorrhagic diathesis or anticoagulation
  • Uncontrolled diabetes or other serious internal comorbidities
  • Allergy to medications or materials used
  • Pregnancy
  • Lack of cooperation
  • Not willing to participate in the study.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis
A total of 34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.
Other: radiofrequency ablation
34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.
Active Comparator: physical therapy for chronic knee osteoarthritis
Thirty-four patients with chronic knee osteoarthritis meeting the criteria will receive 10 sessions of physical therapy.
Other: physical therapy
34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Before treatment (initial), after 2 weeks and 12 weeks changes
Scale. The Visual Analog Scale (VAS) is evaluated on a scale ranging from "no pain" to "worst possible pain." The value of 0 (zero) indicates "no pain," while the value of 10 (ten) indicates "the most severe pain imaginable."
Before treatment (initial), after 2 weeks and 12 weeks changes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Before treatment (initial), after 2 weeks and 12 weeks changes
Questionnaire. The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) test is a disease-specific, valid, and reliable measure for osteoarthritis, comprising 24 questions in three subcategories: pain, stiffness, and physical function. Each question is scored using the Likert scale as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Scores for each section are calculated independently, and the total score ranges from 0 to 100. Higher scores indicate an increase in pain and stiffness, as well as a deterioration in physical function.
Before treatment (initial), after 2 weeks and 12 weeks changes
The 6-minute walk test (6MWT)
Time Frame: Before treatment (initial), after 2 weeks and 12 weeks changes
The 6MWT is an assessment to measure the distance a person is capable of walking on a flat, hard surface in 6 minutes. It is a useful test to measure the response of all the bodily systems that a person uses while exercising.
Before treatment (initial), after 2 weeks and 12 weeks changes
EuroQol scale (EQ-5D-3L)
Time Frame: Before treatment (initial), after 2 weeks and 12 weeks changes

Questionnaire. The EuroQol (EQ) scale, developed by the EuroQol Group, is a general tool for measuring overall quality of life. The EQ-5D-3L (3-level version) is a widely used scale for assessing health status. The EQ-5D-3L consists of two main components: the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS).

In the first component, the EQ-5D descriptive system, health status is evaluated in five dimensions: "Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression." Each dimension has three levels: "1=No problems," "2=Moderate problems," and "3=Severe problems." Combinations derived from these five dimensions create an index score to express individuals' overall health status.

The second component is the visual analog scale (EQ VAS), where the patient self-assesses their health on a vertical visual analog scale with endpoints labeled 'Best imaginable health state=100' and 'Worst imaginable health state=0'.
Before treatment (initial), after 2 weeks and 12 weeks changes

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 15, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Estimated)

December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10026603

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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