Efficacy Ultrasound-guided Genicular Nerve Radiofrequency Treatment

NCT06479642 | Not Yet Recruiting

• 1 other identifier: genicular nerve radiofrequency
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Radiofrequency (RF) application is a treatment method that temporarily blocks pain transmission in the nerve where the application is made, through the heat emitted by radio waves. Genicular nerve ablation with RF has recently become a promising treatment option for the treatment of chronic knee pain. These methods are based on the principle that interfering with the sensory nerve fibers of a painful structure can relieve pain and restore function. Their targets are sensory nerves located on the periosteum before entering the knee joint capsule. The knee joint is innervated by a complex nerve network called genicular nerves, which are articular branches of many nerves such as the femoral, tibial, peroneal, saphenous and obturator nerves. Some of the genicular nerves can be easily localized. The intermedius genicular nerve carries the sensation of subpatellar pain. The intermedius genicular nerve is located under the vastus intermedius muscle, anterior to the distal femoral shaft, just above the bony cortex. Targeting sensory nerves in addition to standard procedures and improving target identification using ultrasound guidance may increase treatment success. The aim of this study is to investigate the effect of ultrasound-guided genicular nerve radiofrequency therapy on pain and knee function by targeting only the traditional 3 genicular nerves and the intermedius genicular nerve in addition to the traditional genicular nerves in advanced gonarthrosis patients with prominent anterior knee pain.

Conditions

Gonarthrosis

Keywords

gonarthrosis; anterior knee pain; radiofrequency

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.

  This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.

• WOMAC

  WOMAC will be used to determine the functional levels of the patients. The WOMAC consists of 24 items and 3 sub- scales. The pain, stiffness, and physical function subscales were reported as adequate in content and construct validity, as well as responsiveness, in patients with KOA.The total score ranges from 0 to 100. High scores indicate an increase in pain and stiffness, impaired physical function

  This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure

Secondary Outcomes (2)

• Kujala Patellofemoral Scoring System

  This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.

• Patella Femoral Pain Severity Scale

  This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.

Study Arms (2)

3 nerves protocol

ACTIVE COMPARATOR

tradiational the three-nerve genicular RF Group (3RFG),

Procedure: Genicular nerve pulse radiofrequency ablation 3

4 nerves protocol

ACTIVE COMPARATOR

targeting the intermedius genicular nerve in addition to traditional genicular nerves four-nerve genicular RF Group (4RFG),

Procedure: Genicular nerve pulse radiofrequency ablation 4

Interventions

Genicular nerve pulse radiofrequency ablation 3 PROCEDURE

Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves

3 nerves protocol

Genicular nerve pulse radiofrequency ablation 4 PROCEDURE

Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves and the intermedius genicular nerve in addition to the traditional genicular nerves.

4 nerves protocol

Eligibility Criteria

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

You may qualify if:

• Being a male/female \>18
• K-L stage 3-4 gonarthrosis patients with anterior knee pain and positive patellofemoral pain tests after physical examination and imaging evaluation
• Those whose symptoms persist for \>3 months
• Participating in the study voluntarily

You may not qualify if:

• Pregnancy
• History of previous knee surgery
• Having received physical therapy in the knee area in the last 3 months
• Having previously undergone RF treatment or having had any therapeutic injection such as steroids or hyaluronic acid within 3 months.
• Those with pain referred to the waist or hip
• Patients with neuropathic pain
• History of tumor, infectious, psychiatric disease, bleeding diathesis
• Having a history of knee trauma in the last 6 months
• Those with systemic diseases such as hepatitis and coagulopathy
• Patients with BMI \>40
• Leg length difference

Sponsors & Collaborators

• Yunus Burak Bayır: lead

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 RESULT

• Guven Kose S, Kirac Unal Z, Kose HC, Celikel F, Akkaya OT. Ultrasound-guided genicular nerve radiofrequency treatment: prospective randomized comparative trial of a 3-nerve protocol versus a 5-nerve protocol. Pain Med. 2023 Jul 5;24(7):758-767. doi: 10.1093/pm/pnad025.

  PMID: 36869680 RESULT

• McCormick ZL, Cohen SP, Walega DR, Kohan L. Technical considerations for genicular nerve radiofrequency ablation: optimizing outcomes. Reg Anesth Pain Med. 2021 Jun;46(6):518-523. doi: 10.1136/rapm-2020-102117. Epub 2021 Jan 22.

  PMID: 33483425 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ayşegül Yaman, specialist

  Ankara Etlik City Hospital

  STUDY CHAIR

• Başak Mansız Kaplan, assoc. prof.

  Ankara Etlik City Hospital

  STUDY CHAIR

Central Study Contacts

YUNUS BURAK BAYIR, specialist

CONTACT

05058083317; yunusburakbayir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physician performing the evaluation will be blind to which procedure is performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yunus Burak Bayır, Principal Investigator

Model Details: Our study was designed as a prospective, single-blind randomized controlled study. Patients who applied to our hospital's PMR outpatient clinic and were diagnosed with advanced stage gonarthrosis with anterior knee pain after physical examination and imaging evaluation will be included in our study. Patients were selected for the first group with the "Research Randomizer" computer program. The patients will be randomized into two groups of 36 people: the three-nerve RF Group (3RFG), the second group will be the four-nerve RF Group (4RFG). The physician performing the evaluation will be blind to which procedure is performed. The demographic and clinical characteristics of the patients will be recorded. Patients will be evaluated using the Visual Analogue Scale (VAS),Patella Femoral Pain Severity Scale and Kujala Patellofemoral Scoring System and WOMAC. These evaluations will be made and recorded at the beginning, at the 4th and 12th weeks after the procedure.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 28, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share