Efficacy Ultrasound-guided Genicular Nerve Radiofrequency Treatment

August 1, 2024 updated by: Yunus Burak Bayır

Ultrasound-guided Genicular Nerve Radiofrequency Treatment:Eficacy of 4-nerve Protocol Versus 3-nerve Protocol

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Our study was designed as a prospective, single-blind randomized controlled study. Patients who applied to our hospital's FTR 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. The sample size was done using G*Power 3.1.9.4 statistical power analysis program for Windows. Based on the study conducted by the effectiveness of genicular RF treatment in chronic knee pain in knee osteoarthritis, the number of patients who will provide a 20% significant change in the pre-treatment and 3rd month WOMAC total evaluation (with a margin of error of 5% Type 1 and 20% Type 2, a study power of 80% and a confidence interval of 95%) is determined for each The minimum required number of patients for a group was found to be 30 patients. Considering that there may be a 20% loss during the study, it was decided to include at least 36 patients for each group. Patients who met the inclusion criteria and completed the "Informed Volunteer Consent Forum" 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)" for knee pain assessment as the primary outcome measure, and the patients will be evaluated for climbing/descending stairs, squatting, walking, jogging, sprinting, sports activities, sitting with knees 90° flexed for 20 minutes, "Patella Femoral Pain Severity Scale" will be used to evaluate the pain that occurs while kneeling, at rest and after an activity, and "Kujala Patellofemoral Scoring System" and WOMAC will be used to determine the functional levels of the patients. These evaluations will be made and recorded at the beginning, at the 4th and 12th weeks after the procedure.

Study Type

Interventional

Enrollment (Estimated)

72

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

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:

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

Exclusion Criteria:

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 nerves protocol
tradiational the three-nerve genicular RF Group (3RFG),
Procedure: Genicular nerve pulse radiofrequency ablation 3
Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves
Active Comparator: 4 nerves protocol
targeting the intermedius genicular nerve in addition to traditional genicular nerves four-nerve genicular RF Group (4RFG),
Procedure: Genicular nerve pulse radiofrequency ablation 4
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
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
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kujala Patellofemoral Scoring System
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
The Kujala patellofemoral score is comprised of 13 questions. These questions inquire whether there is pain during walking up and down stairs, squatting, running, jumping, or prolonged sitting with the knee in flexion; whether there is limping, swelling, or subluxation of the patella; the amount of atrophy in the quadriceps muscle, flexion deficiency, and pain, and whether there is a need for a walking aid. The total score ranges from 0 to 100, the highest indicating the best score
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Patella Femoral Pain Severity Scale
Time Frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Patients' pain, such as climbing stairs, squatting down, walking, jogging, running, participating in a sport, sitting with knees in 90° flexion for 20 minutes, standing on their knees, resting/sleeping, and resting after an activity, was evaluated with PPSS. By describing a line drawn in the form of a ruler and numbers from 0 to 10 (0 as "no pain", 10 as "unbearable pain"). The patients were asked to rate their pain according to this scale, considering the last two days. The total score ranges from 0 to 100, the lowest indicating the best score
This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.

Collaborators and Investigators

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

Sponsor

Yunus Burak Bayır

Investigators

  • Study Chair: Ayşegül Yaman, specialist, Ankara Etlik City Hospital
  • Study Chair: Başak Mansız Kaplan, assoc. prof., Ankara Etlik City Hospital

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • genicular nerve radiofrequency

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.

Clinical Trials on Gonarthrosis

Clinical Trials on Genicular nerve pulse radiofrequency ablation 3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe