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

Chronic Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173830
• Other study ID #: 10026603
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: December 2023
• Source: Ankara City Hospital Bilkent
• Contact: Fatma Gül Yurdakul, Associate Professor (medical)
• Phone: +905059254214
• Email: fatmagulonder[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: April 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• radiofrequency ablation
34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.
• physical therapy
34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital	Ankara	Bilkent - Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. — View Citation

Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9. — View Citation

McCormick ZL, Korn M, Reddy R, Marcolina A, Dayanim D, Mattie R, Cushman D, Bhave M, McCarthy RJ, Khan D, Nagpal G, Walega DR. Cooled Radiofrequency Ablation of the Genicular Nerves for Chronic Pain due to Knee Osteoarthritis: Six-Month Outcomes. Pain Med. 2017 Sep 1;18(9):1631-1641. doi: 10.1093/pm/pnx069. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	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	The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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
Secondary	The 6-minute walk test (6MWT)	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
Secondary	EuroQol scale (EQ-5D-3L)	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