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

NCT06173830 | Unknown

• 1 other identifier: 10026603
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Knee Osteoarthritis

Keywords

knee osteoarthritis; genicular nerve block; Ultrasound; radiofrequency; Chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Before treatment (initial), after 2 weeks and 12 weeks changes

• The 6-minute walk test (6MWT)

  Before treatment (initial), after 2 weeks and 12 weeks changes

• EuroQol scale (EQ-5D-3L)

  Before treatment (initial), after 2 weeks and 12 weeks changes

Study Arms (2)

Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis

ACTIVE COMPARATOR

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

physical therapy for chronic knee osteoarthritis

ACTIVE COMPARATOR

Thirty-four patients with chronic knee osteoarthritis meeting the criteria will receive 10 sessions of physical therapy.

Other: physical therapy

Interventions

radiofrequency ablation OTHER

34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.

Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis

physical therapy OTHER

34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.

physical therapy for chronic knee osteoarthritis

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Bilkent - Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 21055873 BACKGROUND

• 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.

  PMID: 28431129 BACKGROUND

• 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.

  PMID: 27389118 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Radiofrequency Ablation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Rehabilitation

Central Study Contacts

Fatma Gül Yurdakul, Associate Professor (medical)

CONTACT

+905059254214; fatmagulonder@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 18, 2023
• Study Start: October 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: April 15, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)