Osteoarthritis of KneeGRFT-PRFNCT06894147
Genicular Radiofrequency Ablation Versus Pulsed Radiofrequency
A study testing Genicular nerve pulse radiofrequency in people with Osteoarthritis of Knee, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effectiveness of two treatments-genicular nerve radiofrequency ablation and pulsed radiofrequency-in reducing pain and improving function in osteoarthritis patients. These techniques, used after diagnostic nerve blocks, aim to provide long-lasting pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Genicular nerve pulse radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 May 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
- patients over the age of 18
- osteoarthritis
- Grade 2-4 gonarthrosis according to the Kellgren-Lawrence (KL) classification
- Pain 6-10 on the Numeric Rating Scale (NRS)
Who cannot join
- Patients with chronic knee pain due to another pathology (e.g., meniscopathy, trauma, rheumatoid arthritis) History of previous knee surgery History of intra-articular injection in the last 3 months Coagulopathy, use of antiplatelet or anticoagulant medications Infection Severe psychiatric disorders Patients with a cardiac pacemaker or defibrillator Renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Cankaya, 06680
About this study
Official title: "Comparison of the Effects of Genicular Radiofrequency Ablation and Pulsed Radiofrequency Applications on Pain Levels in Patients With Osteoarthritis, Guided by Ultrasound''
This study investigates the effectiveness of two treatments-genicular nerve radiofrequency ablation and pulsed radiofrequency-in reducing pain and improving function in osteoarthritis patients. These techniques, used after diagnostic nerve blocks, aim to provide long-lasting pain relief. Despite both being found effective, no clear consensus exists on which method is superior. The study seeks to compare these techniques and contribute new insights to the existing literature.
Read the detailed description
Chronic knee pain, especially in osteoarthritis patients, is a common condition that significantly affects mobility and quality of life. In individuals over the age of 60, the incidence is 9.6% in men and 18% in women. In patients with osteoarthritis, weight loss and appropriate exercises are recommended as the primary treatments. This is followed by medical therapy, injection treatments, and, if necessary, total knee arthroplasty. However, for patients with a body mass index (BMI) of 40 or higher, total knee arthroplasty is avoided due to the high surgical risk. In recent years, genicular nerve diagnostic block and radiofrequency ablation have been shown to reduce pain and improve function in these patients . Radiofrequency ablation works by blocking the transmission of sensory nerves, thereby improving function.
The innervation of the knee joint originates from the femoral nerve's articular branches, the common peroneal, saphenous, tibial, and obturator nerves. These articular branches are known as the genicular nerves, which are superficial and can be easily accessed using both fluoroscopy and ultrasound.
In osteoarthritis patients, superior medial, superior lateral, and inferior medial genicular nerve blocks are applied. After the diagnostic block, some clinics apply radiofrequency thermocoagulation to the genicular nerve branches for a lasting effect, while others use pulsed radiofrequency. Both techniques have been found to be effective, but there is no data in the literature regarding which technique is superior. The aim of this study is to determine which of the two techniques is more effective and share the findings with the literature.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Genicular nerve pulse radiofrequency
- Keywords
- Osteoarthritis of Knee, Pulsed Radio Frequency Treatment, Radiofrequency Ablation
- 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 radiofrequencyProcedure or surgery
After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo pulsed radiofrequency aplication.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Experimental | After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo radiofrequency ablation on the genicular nerve branches. Receives: Procedure: Genicular nerve pulse radiofrequency |
| Pulsed radiofrequency | Experimental | After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo either pulsed radiofrequency on the genicular nerve branches. Receives: Procedure: Genicular nerve pulse radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) ,
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable
Measured: Baseline, 3 weeks, 3 months.
Secondary outcomes (1)
Western Ontario and McMaster (WOMAC) Osteoarthritis Index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright.
Measured: Baseline, 3 weeks, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Randomized Controlled, Double-Blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Sabuncu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894147
- Sponsor's protocol ID
- TABED-1-24-88
- Acronym
- GRFT-PRF
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: privacy.
Publications
Kirdemir P, Catav S, Alkaya Solmaz F. The genicular nerve: radiofrequency lesion application for chronic knee pain. Turk J Med Sci. 2017 Feb 27;47(1):268-272. doi: 10.3906/sag-1601-171.
PubMed 28263500Fitzpatrick B, Cowling M, Poliak-Tunis M, Miller K. Effect of Genicular Nerve Radiofrequency Ablation for Knee Osteoarthritis: A Retrospective Chart Review. WMJ. 2021 Jul;120(2):156-159.
PubMed 34255959
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of the Effects of Genicular Radiofrequency Ablation and Pulsed Radiofrequency Applications on Pain Levels in Patients With Osteoarthritis, Guided by Ultrasound''
- ClinicalTrials.gov ID
- NCT06894147
- Acronym / sponsor ID
- GRFT-PRF / TABED-1-24-88
- Conditions
- Osteoarthritis of Knee
- Keywords
- Osteoarthritis of Knee, Pulsed Radio Frequency Treatment, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 Mar 2025 (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.
This study investigates the effectiveness of two treatments-genicular nerve radiofrequency ablation and pulsed radiofrequency-in reducing pain and improving function in osteoarthritis patients. These techniques, used after diagnostic nerve blocks, aim to provide long-lasting pain relief. Despite both being found effective, no clear consensus exists on which method is superior. The study seeks to compare these techniques and contribute new insights to the existing literature.
Detailed description
Chronic knee pain, especially in osteoarthritis patients, is a common condition that significantly affects mobility and quality of life. In individuals over the age of 60, the incidence is 9.6% in men and 18% in women. In patients with osteoarthritis, weight loss and appropriate exercises are recommended as the primary treatments. This is followed by medical therapy, injection treatments, and, if necessary, total knee arthroplasty. However, for patients with a body mass index (BMI) of 40 or higher, total knee arthroplasty is avoided due to the high surgical risk. In recent years, genicular nerve diagnostic block and radiofrequency ablation have been shown to reduce pain and improve function in these patients . Radiofrequency ablation works by blocking the transmission of sensory nerves, thereby improving function.
The innervation of the knee joint originates from the femoral nerve's articular branches, the common peroneal, saphenous, tibial, and obturator nerves. These articular branches are known as the genicular nerves, which are superficial and can be easily accessed using both fluoroscopy and ultrasound.
In osteoarthritis patients, superior medial, superior lateral, and inferior medial genicular nerve blocks are applied. After the diagnostic block, some clinics apply radiofrequency thermocoagulation to the genicular nerve branches for a lasting effect, while others use pulsed radiofrequency. Both techniques have been found to be effective, but there is no data in the literature regarding which technique is superior. The aim of this study is to determine which of the two techniques is more effective and share the findings with the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled, Double-Blind
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Experimental | Procedure: Genicular nerve pulse radiofrequencyAfter performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo radiofrequency ablation on the genicular nerve branches. |
| Pulsed radiofrequency | Experimental | Procedure: Genicular nerve pulse radiofrequencyAfter performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo either pulsed radiofrequency on the genicular nerve branches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over the age of 18
- osteoarthritis
- Grade 2-4 gonarthrosis according to the Kellgren-Lawrence (KL) classification
- Pain 6-10 on the Numeric Rating Scale (NRS)
Key exclusion criteria (1 listed)
- Patients with chronic knee pain due to another pathology (e.g., meniscopathy, trauma, rheumatoid arthritis) History of previous knee surgery History of intra-articular injection in the last 3 months Coagulopathy, use of antiplatelet or anticoagulant medications Infection Severe psychiatric disorders Patients with a cardiac pacemaker or defibrillator Renal or hepatic failure
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 radiofrequencyAfter performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo pulsed radiofrequency aplication. | Procedure or surgery | Pulsed radiofrequency, Radiofrequency ablation |
Primary outcome
Numeric rating scale (NRS) ,
Time frame: Baseline, 3 weeks, 3 months.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable
1 secondary outcome
Western Ontario and McMaster (WOMAC) Osteoarthritis Index
Time frame: Baseline, 3 weeks, 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Results publication: PubMed 28263500Kirdemir P, Catav S, Alkaya Solmaz F. The genicular nerve: radiofrequency lesion application for chronic knee pain. Turk J Med Sci. 2017 Feb 27;47(1):268-272. doi: 10.3906/sag-1601-171.
- Results publication: PubMed 34255959Fitzpatrick B, Cowling M, Poliak-Tunis M, Miller K. Effect of Genicular Nerve Radiofrequency Ablation for Knee Osteoarthritis: A Retrospective Chart Review. WMJ. 2021 Jul;120(2):156-159.
- Individual participant dataSharing planned: No. privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular nerve pulse radiofrequency in people with Osteoarthritis of Knee, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) , (time frame: Baseline, 3 weeks, 3 months.). 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 NCT06894147, which also lists 2 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 25 Mar 2025.