Knee OsteoarthristisGEN-AL-RFNCT07537335
Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis
A study testing genicular nerve block in people with Knee Osteoarthristis and Radiofrequency Ablation, run by Sakarya University.
Trial summary
The GEN-AL-RF study is a randomized controlled trial designed to compare the clinical efficacy of two interventional techniques for managing chronic knee pain due to osteoarthritis. The study focuses on genicular nerve radiofrequency (RF) ablation versus neurolytic alcohol injection for pain blockade. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthristis, Radiofrequency Ablation, NEUROLYSIS
- What is being tested?
- genicular nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Patients aged 45 to 85 years.
- Diagnosis: Chronic knee pain for at least 6 months diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
- Radiological Grade: Grade 3 or 4 according to the Kellgren-Lawrence (K-L) classification.
- Pain Severity: Baseline Numerical Rating Scale (NRS) score of 5 or higher.
- Failure of Conservative Treatment: Inadequate response to conservative treatments (e.g., physical therapy, NSAIDs, or intra-articular injections) for at least 3 months.
- Positive Diagnostic Block: At least 50% reduction in pain for minimum 24 hours following a prognostic genicular nerve block with local anesthetic.
Who cannot join
- Previous Surgery: History of knee arthroplasty or major knee surgery on the affected side.
- Specific Conditions: Presence of inflammatory arthritis (e.g., rheumatoid arthritis), gouty arthritis, or active infection at the injection site.
- Neurological Deficit: Severe neurological or psychiatric disorders that may interfere with pain assessment.
- Coagulopathy: Uncontrolled bleeding disorders or use of anticoagulant therapy that cannot be temporarily discontinued.
- Recent Injections: Intra-articular steroid or hyaluronic acid injection within the last 3 months.
- Allergy: Known allergy to local anesthetics, contrast agents, or ethyl alcohol.
- Pacemaker: Presence of a cardiac pacemaker or implanted electronic device (specifically for the RFA group).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Genicular Nerve Radiofrequency Ablation and Neurolytic Alcohol Injection for Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial
The GEN-AL-RF study is a randomized controlled trial designed to compare the clinical efficacy of two interventional techniques for managing chronic knee pain due to osteoarthritis. The study focuses on genicular nerve radiofrequency (RF) ablation versus neurolytic alcohol injection for pain blockade.
Patients diagnosed with knee osteoarthritis are randomly assigned to either the RF ablation group or the neurolytic alcohol group. The primary objective is to evaluate the superiority and duration of analgesic effects between these two methods. Clinical outcomes are assessed at baseline and at 1, 3, and 6 months post-procedure using the Numeric Rating Scale (NRS) for pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for physical function, and the Short Form-12 (SF-12) for health-related quality of life.
The results of this study aim to provide high-quality evidence regarding the comparative effectiveness and long-term outcomes of genicular nerve RF and alcohol neurolysis in the clinical management of chronic knee osteoarthritis pain.
Read the detailed description
The GEN-AL-RF study investigates the clinical outcomes of two ultrasound-guided genicular nerve procedures in patients with Grade 3-4 knee osteoarthritis according to Kellgren-Lawrence criteria. Patients who have failed conservative treatment options are enrolled and randomly assigned to one of two intervention groups.
Under real-time ultrasound guidance, the superior medial, superior lateral, and inferior medial genicular nerves are targeted. In the Thermal Radiofrequency (RF) group, patients receive RF ablation at 75°C for 90 seconds per target nerve. In the Neurolytic Alcohol group, 1 mL of absolute ethanol is injected at each of the three anatomical targets. Both procedures are performed by experienced physicians using standardized needle placement techniques.
Clinical assessments are conducted at baseline and at follow-up intervals of 1, 3, and 6 months. The primary outcome is pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes include physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and health-related quality of life measured by the Short Form-12 (SF-12) survey. Safety is monitored throughout the study period by documenting any procedure-related adverse events.
- Conditions
- Knee Osteoarthristis, Radiofrequency Ablation, NEUROLYSIS
- Being tested
- genicular nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve blockOther
Also called genicular nerve chemical neurolysis, genicular nerve radiofrequency ablation
Genicular nerve radiofrequency ablation : Patients will undergo ultrasound or fluoroscopy-guided radiofrequency ablation of the genicular nerves (superior medial, superior lateral, and inferior medial). The procedure involves placing RF cannulas at the target neural sites. Once the position is confirmed by sensory and motor stimulation, thermal radiofrequency lesioning will be performed to disrupt pain signal transmission.
Genicular nerve chemichal neurolysis: Patients will receive ultrasound or fluoroscopy-guided chemical neurolysis of the genicular nerves (superior medial, superior lateral, and inferior medial). Following correct needle placement confirmed by contrast spread or local anesthetic test block, a specific volume (1 mL per nerve) of ethyl alcohol (95-96% concentration) will be injected to achieve long-term neurolytic blockade of the target nerves.
| Study group | Role | What they receive |
|---|---|---|
| Genicular Nerve Thermal Radiofrequency Ablation | Active comparator | Patients in this group will receive conventional thermal radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves. The procedure will be performed at 80°C for 90 seconds per site under ultrasound guidance to achieve thermal neurocoagulation. Receives: Other: genicular nerve block |
| Genicular Nerve Chemical Neurolysis (Alcohol) | Experimental | Patients will receive chemical neurolysis of the superior medial, superior lateral, and inferior medial genicular nerves. 95% ethyl alcohol (1mL per site) will be injected at the target locations to achieve chemical neurodestruction of the sensory nerves. Receives: Other: genicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Numeric Rating Scale (NRS) Score at 6 Months.
The Numeric Rating Scale (NRS) is a segmented numerical version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The score ranges from 0 (no pain) to 10 (worst possible pain). A decrease in score indicates pain relief.
Measured: 1 month, 3 months, and 6 months.
Secondary outcomes (2)
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
The WOMAC is a proprietary set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including segments for pain, stiffness, and physical function. Higher scores indicate worse outcomes.
Measured: 1 month, 3 months, and 6 months post-procedure.
Change from Baseline in 12-Item Short Form Health Survey (SF-12) Score.
The SF-12 is a self-reported outcome measure assessing health-related quality of life. It yields two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better physical and mental health.
Measured: 1 month, 3 months, and 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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 Sakarya UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537335
- Sponsor's protocol ID
- E.567659-139
- Acronym
- GEN-AL-RF
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Genicular Nerve Radiofrequency Ablation and Neurolytic Alcohol Injection for Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07537335
- Acronym / sponsor ID
- GEN-AL-RF / E.567659-139
- Conditions
- Knee Osteoarthristis, Radiofrequency Ablation, NEUROLYSIS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Apr 2026 (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.
The GEN-AL-RF study is a randomized controlled trial designed to compare the clinical efficacy of two interventional techniques for managing chronic knee pain due to osteoarthritis. The study focuses on genicular nerve radiofrequency (RF) ablation versus neurolytic alcohol injection for pain blockade.
Patients diagnosed with knee osteoarthritis are randomly assigned to either the RF ablation group or the neurolytic alcohol group. The primary objective is to evaluate the superiority and duration of analgesic effects between these two methods. Clinical outcomes are assessed at baseline and at 1, 3, and 6 months post-procedure using the Numeric Rating Scale (NRS) for pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for physical function, and the Short Form-12 (SF-12) for health-related quality of life.
The results of this study aim to provide high-quality evidence regarding the comparative effectiveness and long-term outcomes of genicular nerve RF and alcohol neurolysis in the clinical management of chronic knee osteoarthritis pain.
Detailed description
The GEN-AL-RF study investigates the clinical outcomes of two ultrasound-guided genicular nerve procedures in patients with Grade 3-4 knee osteoarthritis according to Kellgren-Lawrence criteria. Patients who have failed conservative treatment options are enrolled and randomly assigned to one of two intervention groups.
Under real-time ultrasound guidance, the superior medial, superior lateral, and inferior medial genicular nerves are targeted. In the Thermal Radiofrequency (RF) group, patients receive RF ablation at 75°C for 90 seconds per target nerve. In the Neurolytic Alcohol group, 1 mL of absolute ethanol is injected at each of the three anatomical targets. Both procedures are performed by experienced physicians using standardized needle placement techniques.
Clinical assessments are conducted at baseline and at follow-up intervals of 1, 3, and 6 months. The primary outcome is pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes include physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and health-related quality of life measured by the Short Form-12 (SF-12) survey. Safety is monitored throughout the study period by documenting any procedure-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genicular Nerve Thermal Radiofrequency Ablation | Active comparator | Other: genicular nerve blockPatients in this group will receive conventional thermal radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves. The procedure will be performed at 80°C for 90 seconds per site under ultrasound guidance to achieve thermal neurocoagulation. |
| Genicular Nerve Chemical Neurolysis (Alcohol) | Experimental | Other: genicular nerve blockPatients will receive chemical neurolysis of the superior medial, superior lateral, and inferior medial genicular nerves. 95% ethyl alcohol (1mL per site) will be injected at the target locations to achieve chemical neurodestruction of the sensory nerves. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Patients aged 45 to 85 years.
- Diagnosis: Chronic knee pain for at least 6 months diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
- Radiological Grade: Grade 3 or 4 according to the Kellgren-Lawrence (K-L) classification.
- Pain Severity: Baseline Numerical Rating Scale (NRS) score of 5 or higher.
- Failure of Conservative Treatment: Inadequate response to conservative treatments (e.g., physical therapy, NSAIDs, or intra-articular injections) for at least 3 months.
Key exclusion criteria (7 listed)
- Previous Surgery: History of knee arthroplasty or major knee surgery on the affected side.
- Specific Conditions: Presence of inflammatory arthritis (e.g., rheumatoid arthritis), gouty arthritis, or active infection at the injection site.
- Neurological Deficit: Severe neurological or psychiatric disorders that may interfere with pain assessment.
- Coagulopathy: Uncontrolled bleeding disorders or use of anticoagulant therapy that cannot be temporarily discontinued.
- Recent Injections: Intra-articular steroid or hyaluronic acid injection within the last 3 months.
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 blockAlso: genicular nerve chemical neurolysis, genicular nerve radiofrequency ablationGenicular nerve radiofrequency ablation : Patients will undergo ultrasound or fluoroscopy-guided radiofrequency ablation of the genicular nerves (superior medial, superior lateral, and inferior medial). The procedure involves placing RF cannulas at the target neural sites. Once the position is confirmed by sensory and motor stimulation, thermal radiofrequency lesioning will be performed to disrupt pain signal transmission. Genicular nerve chemichal neurolysis: Patients will receive ultrasound or fluoroscopy-guided chemical neurolysis of the genicular nerves (superior medial, superior lateral, and inferior medial). Following correct needle placement confirmed by contrast spread or local anesthetic test block, a specific volume (1 mL per nerve) of ethyl alcohol (95-96% concentration) will be injected to achieve long-term neurolytic blockade of the target nerves. | Other | Genicular Nerve Chemical Neurolysis (Alcohol), Genicular Nerve Thermal Radiofrequency Ablation |
Primary outcome
Change from Baseline in Numeric Rating Scale (NRS) Score at 6 Months.
Time frame: 1 month, 3 months, and 6 months.
The Numeric Rating Scale (NRS) is a segmented numerical version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The score ranges from 0 (no pain) to 10 (worst possible pain). A decrease in score indicates pain relief.
2 secondary outcomes
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: 1 month, 3 months, and 6 months post-procedure.
Change from Baseline in 12-Item Short Form Health Survey (SF-12) Score.
Time frame: 1 month, 3 months, and 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing genicular nerve block in people with Knee Osteoarthristis and Radiofrequency Ablation, run by Sakarya University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact murat erten (+905435118202, muraterten37@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Numeric Rating Scale (NRS) Score at 6 Months. (time frame: 1 month, 3 months, and 6 months.). 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 17 Apr 2026.