GonarthrosisNCT06479642
Efficacy Ultrasound-guided Genicular Nerve Radiofrequency Treatment
A study testing Genicular nerve pulse radiofrequency ablation 3 and Genicular nerve pulse radiofrequency ablation 4 in people with Gonarthrosis, run by Yunus Burak Bayır.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Genicular nerve pulse radiofrequency ablation 3 and Genicular nerve pulse radiofrequency ablation 4
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gonarthrosis
- Being tested
- Genicular nerve pulse radiofrequency ablation 3, Genicular nerve pulse radiofrequency ablation 4
- Keywords
- gonarthrosis, anterior knee pain, radiofrequency
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular nerve pulse radiofrequency ablation 3Procedure or surgery
Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves
Genicular nerve pulse radiofrequency ablation 4Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 nerves protocol | Active comparator | tradiational the three-nerve genicular RF Group (3RFG), Receives: 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), Receives: Procedure: Genicular nerve pulse radiofrequency ablation 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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
Measured: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Patella Femoral Pain Severity Scale
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
Measured: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Burak Bayır
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yunus Burak Bayır, Ankara Etlik City Hospital
- Investigators
- Ayşegül Yaman, specialist, Study chair, Ankara Etlik City HospitalBaşak Mansız Kaplan, assoc. prof., Study chair, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479642
- Sponsor's protocol ID
- genicular nerve radiofrequency
- Status last verified
- Aug 2024
- First submitted
- 11 Jun 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21055873Guven 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.
PubMed 36869680McCormick 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.
PubMed 33483425
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Genicular Nerve Radiofrequency Treatment:Eficacy of 4-nerve Protocol Versus 3-nerve Protocol
- ClinicalTrials.gov ID
- NCT06479642
- Acronym / sponsor ID
- genicular nerve radiofrequency
- Conditions
- Gonarthrosis
- Keywords
- gonarthrosis, anterior knee pain, radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Yunus Burak BayırOther government
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3 nerves protocol | Active comparator | Procedure: Genicular nerve pulse radiofrequency ablation 3tradiational the three-nerve genicular RF Group (3RFG), |
| 4 nerves protocol | Active comparator | Procedure: Genicular nerve pulse radiofrequency ablation 4targeting the intermedius genicular nerve in addition to traditional genicular nerves four-nerve genicular RF Group (4RFG), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular nerve pulse radiofrequency ablation 3Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves | Procedure or surgery | 3 nerves protocol |
| Genicular nerve pulse radiofrequency ablation 4Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves and the intermedius genicular nerve in addition to the traditional genicular nerves. | Procedure or surgery | 4 nerves protocol |
Primary outcome
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.
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
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Results publication: PubMed 21055873Choi 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.
- Results publication: PubMed 36869680Guven 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.
- Results publication: PubMed 33483425McCormick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşegül Yaman, specialist study chair
Ankara Etlik City Hospital
Başak Mansız Kaplan, assoc. prof. study chair
Ankara Etlik City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Genicular nerve pulse radiofrequency ablation 3 and Genicular nerve pulse radiofrequency ablation 4 in people with Gonarthrosis, run by Yunus Burak Bayır.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YUNUS BURAK BAYIR, specialist (05058083317, yunusburakbayir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479642, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.