Knee OsteoarthristisGNRFT & IAPRFNCT07098455
Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain
A study testing GNRFT- genicular nerve radiofrequency ablation and IAPRF- Intraarticular pulsed radiofrequency in people with Knee Osteoarthristis and Radiofrequency Ablation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis, Radiofrequency Ablation
- What is being tested?
- GNRFT- genicular nerve radiofrequency ablation and IAPRF- Intraarticular pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2025to 20 Apr 2026
- 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 18 years of age;
- Patients who have pain due to knee osteoarthritis
- Patients who agree to undergo knee geniculate nerve thermocoagulation or knee intra-articular pulsed radiofrequency therapy and follow-up.
Who cannot join
- Patients using anticoagulants and those with coagulation disorders,
- Patients with psychomotor disorders,
- Patients who have undergone intra-articular injections, interventional procedures, or surgery for knee osteoarthritis in the last year,
- Patients with bacterial infection or infectious discharge in the area to be treated,
- Patients with allergies to local anesthetics, and pregnant and breastfeeding patients
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. The prevalence of secondary chronic knee pain in OA is more than 12% in individuals over the age of 60. It is one of the most common musculoskeletal disorders in elderly patients and has become a global health problem. Standard treatments for OA include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, opioids, intra-articular hyaluronic acid, or steroids. In more severe cases, surgical knee arthroplasty should be considered. But long-term use of NSAIDs is associated with stomach bleeding, adverse cardiovascular events, and kidney failure. Opioids are often used, but a large number of side effects are encountered, especially in the elderly. Knee surgery is not always possible and can cause complications such as hematomas, infections, and damage to the surrounding tissue.
Radiofrequency (RF) application (pulsed or continuous) is a neuromodulatory or neurolytic technique that represents an alternative in pain due to osteoarthritis. RF therapy is one of the conservative treatments that has many advantages, such as minimal invasiveness, rapid recovery, and less negative response. Radiofrequency thermocoagulation (RFT) destroys the integrity of peripheral nerves using hyperthermia and thereby blocks the transmission of pain signals, while pulsed radiofrequency (PRF) regulates neurological functions or inhibits the production of immunoinflammatory factors (e.g., IL-1β, TNF-α, IL-6) by using electric fields to affect their production, thereby relieving pain in patients.
Genicular nerve radiofrequency thermocoagulation application and knee intra-articular pulsed radiofrequency application are the two radiofrequency methods routinely applied in the treatment of gonarthrosis-induced pain in our clinic. In this study, it is aimed to evaluate the effectiveness of these two methods and compare their outcomes.
- Conditions
- Knee Osteoarthristis, Radiofrequency Ablation
- Being tested
- GNRFT- genicular nerve radiofrequency ablation, IAPRF- Intraarticular pulsed radiofrequency
- Keywords
- Osteoarthritis of Knee, Pulsed Radiofrequency 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.
GNRFT- genicular nerve radiofrequency ablationProcedure or surgery
Ultrasound-guided genicular nerve radiofrequency ablation will be performed
IAPRF- Intraarticular pulsed radiofrequencyProcedure or surgery
Intra-articular pulsed radiofrequency will be applied under fluoroscopy guidance.
| Study group | Role | What they receive |
|---|---|---|
| GNRFT - Genicular Nerve Radiofrequency Ablation | Experimental | Patients in this group will undergo ultrasound-guided genicular nerve radiofrequency ablation. Receives: Procedure: GNRFT- genicular nerve radiofrequency ablation |
| IAPRF - Intra-articular pulsed radiofrequency | Experimental | KNEE INTRAARTICULAR PULSED RADIOFREQUENCY WILL BE APPLIED TO PATIENTS IN THIS GROUP Receives: Procedure: IAPRF- Intraarticular pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Pain intensity was measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients rated their pain intensity based on their average pain during the defined time frame. Changes in NRS scores over time were used to evaluate treatment response.
Measured: baseline, at the 3rd month
Secondary outcomes (2)
GPE
Overall patient-perceived change in symptoms was assessed using the Global Perceived Effect scale. Patients rated their overall condition compared with baseline on a Likert-type scale ranging from "very much worse" to "very much improved." The GPE was used to capture the patient's global assessment of treatment effectiveness.
Measured: baseline, 3rd month
WOMAC
Functional status was assessed using the WOMAC questionnaire, a validated disease-specific instrument for osteoarthritis. The WOMAC consists of 24 items across three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Higher scores indicate worse pain, stiffness, and functional limitation.
Measured: baseline; 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start21 Aug 2025
- Primary completion1 Mar 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali ÇOŞTU, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098455
- Sponsor's protocol ID
- E2-25-10611
- Acronym
- GNRFT & IAPRF
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT07098455
- Acronym / sponsor ID
- GNRFT & IAPRF / E2-25-10611
- Conditions
- Knee Osteoarthristis, Radiofrequency Ablation
- Keywords
- Osteoarthritis of Knee, Pulsed Radiofrequency Treatment, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 1 Aug 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.
Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. The prevalence of secondary chronic knee pain in OA is more than 12% in individuals over the age of 60. It is one of the most common musculoskeletal disorders in elderly patients and has become a global health problem. Standard treatments for OA include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, opioids, intra-articular hyaluronic acid, or steroids. In more severe cases, surgical knee arthroplasty should be considered. But long-term use of NSAIDs is associated with stomach bleeding, adverse cardiovascular events, and kidney failure. Opioids are often used, but a large number of side effects are encountered, especially in the elderly. Knee surgery is not always possible and can cause complications such as hematomas, infections, and damage to the surrounding tissue.
Radiofrequency (RF) application (pulsed or continuous) is a neuromodulatory or neurolytic technique that represents an alternative in pain due to osteoarthritis. RF therapy is one of the conservative treatments that has many advantages, such as minimal invasiveness, rapid recovery, and less negative response. Radiofrequency thermocoagulation (RFT) destroys the integrity of peripheral nerves using hyperthermia and thereby blocks the transmission of pain signals, while pulsed radiofrequency (PRF) regulates neurological functions or inhibits the production of immunoinflammatory factors (e.g., IL-1β, TNF-α, IL-6) by using electric fields to affect their production, thereby relieving pain in patients.
Genicular nerve radiofrequency thermocoagulation application and knee intra-articular pulsed radiofrequency application are the two radiofrequency methods routinely applied in the treatment of gonarthrosis-induced pain in our clinic. In this study, it is aimed to evaluate the effectiveness of these two methods and compare their outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNRFT - Genicular Nerve Radiofrequency Ablation | Experimental | Procedure: GNRFT- genicular nerve radiofrequency ablationPatients in this group will undergo ultrasound-guided genicular nerve radiofrequency ablation. |
| IAPRF - Intra-articular pulsed radiofrequency | Experimental | Procedure: IAPRF- Intraarticular pulsed radiofrequencyKNEE INTRAARTICULAR PULSED RADIOFREQUENCY WILL BE APPLIED TO PATIENTS IN THIS GROUP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age;
- Patients who have pain due to knee osteoarthritis
- Patients who agree to undergo knee geniculate nerve thermocoagulation or knee intra-articular pulsed radiofrequency therapy and follow-up.
Key exclusion criteria (5 listed)
- Patients using anticoagulants and those with coagulation disorders,
- Patients with psychomotor disorders,
- Patients who have undergone intra-articular injections, interventional procedures, or surgery for knee osteoarthritis in the last year,
- Patients with bacterial infection or infectious discharge in the area to be treated,
- Patients with allergies to local anesthetics, and pregnant and breastfeeding patients
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 |
|---|---|---|
| GNRFT- genicular nerve radiofrequency ablationUltrasound-guided genicular nerve radiofrequency ablation will be performed | Procedure or surgery | GNRFT - Genicular Nerve Radiofrequency Ablation |
| IAPRF- Intraarticular pulsed radiofrequencyIntra-articular pulsed radiofrequency will be applied under fluoroscopy guidance. | Procedure or surgery | IAPRF - Intra-articular pulsed radiofrequency |
Primary outcome
NRS
Time frame: baseline, at the 3rd month
Pain intensity was measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients rated their pain intensity based on their average pain during the defined time frame. Changes in NRS scores over time were used to evaluate treatment response.
2 secondary outcomes
GPE
Time frame: baseline, 3rd month
WOMAC
Time frame: baseline; 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
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 GNRFT- genicular nerve radiofrequency ablation and IAPRF- Intraarticular pulsed radiofrequency in people with Knee Osteoarthristis and Radiofrequency Ablation, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NRS (time frame: baseline, at the 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.