Knee OsteoarthritisNCT07267039
Phenol Neurolysis Versus Local Anesthetic Plus Steroid Genicular Nerve Block in Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Genicular Nerve Block, run by Salim Sencar at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate two different ultrasound-guided procedures for patients with knee osteoarthritis (gonarthrosis) who did not benefit from conservative treatments. The first method is genicular nerve neurolysis with phenol, a chemical agent that blocks nerve signals and may reduce pain for a longer period. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Genicular Nerve Block
- What is being tested?
- Phenol Injection and Bupivacaine + Triamcinolone Acetonide Injection
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥40 years) diagnosed with moderate to severe knee osteoarthritis (Kellgren-Lawrence grade 3-4) who did not benefit from conservative treatments such as medications and physical therapy. A total of 42 patients are enrolled and treated at the Physical Medicine and Rehabilitation Department, Ondokuz Mayis University, Faculty of Medicine, Samsun, Turkey.
Who may be able to join
- Age ≥ 40 years
- Diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 3-4) confirmed by radiographic evaluation
- Moderate to severe knee pain for at least 3 months (VAS ≥ 4)
- Inadequate response to conservative treatments (e.g., medications, physical therapy, exercise)
- Ability to provide informed consent
Who cannot join
- History of knee surgery (e.g., total knee arthroplasty) on the affected side
- Intra-articular injection (hyaluronic acid, corticosteroid, PRP, etc.) within the last 6 months
- Secondary arthritis (e.g., rheumatoid arthritis, gout, septic arthritis, trauma-related arthritis)
- Severe coagulopathy or current use of anticoagulant therapy contraindicating injection
- Local skin infection at the injection site
- Known allergy or contraindication to phenol, bupivacaine, or triamcinolone acetonide
- Severe uncontrolled systemic disease (e.g., advanced cardiac, hepatic, or renal failure)
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Samsun, 55139
About this study
Official title: Comparison of Phenol Neurolysis and Local Anesthetic Plus Steroid Genicular Nerve Block Under Ultrasound Guidance in Patients With Knee Osteoarthritis: Effects on Pain, Function, and Safety
This study aims to evaluate two different ultrasound-guided procedures for patients with knee osteoarthritis (gonarthrosis) who did not benefit from conservative treatments. The first method is genicular nerve neurolysis with phenol, a chemical agent that blocks nerve signals and may reduce pain for a longer period. The second method is a genicular nerve block with local anesthetic (bupivacaine) and corticosteroid (triamcinolone acetonide), which is commonly used to relieve pain and inflammation.
A total of 42 patients are followed prospectively. Pain intensity is measured using the Visual Analog Scale (VAS), and functional outcomes are assessed with the WOMAC Index and Oxford Knee Score (OKS). Joint range of motion, need for pain medications, and possible side effects are also monitored.
The results will help to compare the effectiveness and safety of phenol neurolysis and triamcinolone acetonide-local anesthetic nerve block, and may guide future treatment choices for patients with knee osteoarthritis.
Read the detailed description
Knee osteoarthritis (gonarthrosis) is a major cause of chronic pain and disability. Patients who fail to respond to conservative treatments such as medications, physical therapy, and exercise often require interventional options for pain relief.
This prospective observational cohort study compares two ultrasound-guided procedures targeting the genicular nerves of the knee:
Genicular nerve neurolysis with phenol - phenol induces protein denaturation and Wallerian degeneration in nerve fibers, providing long-term analgesia.
Genicular nerve block with local anesthetic (bupivacaine) and corticosteroid (triamcinolone acetonide) - this combination offers immediate pain reduction from nerve blockade and potential prolonged relief due to the anti-inflammatory action of the steroid.
A total of 42 patients with Kellgren-Lawrence grade 3-4 knee osteoarthritis and moderate-to-severe pain (VAS ≥ 4 for ≥ 3 months) are prospectively followed. Interventions are performed under ultrasound guidance at the superomedial, superolateral, and inferomedial genicular nerves.
The primary outcome is change in pain severity (VAS). Secondary outcomes include functional improvement assessed by the WOMAC Index and Oxford Knee Score (OKS), joint range of motion, need for nonsteroidal anti-inflammatory drugs (NSAIDs), and procedure-related adverse events. Assessments are performed at baseline, 2 weeks, and 3 months post-procedure.
The study aims to provide comparative evidence on the effectiveness and safety of phenol neurolysis versus triamcinolone acetonide-local anesthetic block, helping to guide clinical practice in the management of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis, Genicular Nerve Block
- Being tested
- Phenol Injection, Bupivacaine + Triamcinolone Acetonide Injection
- Keywords
- Knee Osteoarthritis, Gonarthrosis, Genicular Nerve Block, Genicular Nerve Neurolysis, Phenol, Bupivacaine, Triamcinolone Acetonide
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenol InjectionDrug
Also called Phenol Neurolysis
Ultrasound-guided genicular nerve neurolysis performed at the superomedial, superolateral, and inferomedial genicular nerves. A 22G, 50 mm insulated needle is placed under ultrasound guidance, and 2 mL of 6% phenol is injected at each target site for chemical neurolysis.
Bupivacaine + Triamcinolone Acetonide InjectionDrug
Also called Local Anesthetic + Steroid Block
Ultrasound-guided genicular nerve block performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of a solution containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected using a 22G, 50 mm insulated needle. This provides both local anesthetic and anti-inflammatory effects.
| Study group | Role | What they receive |
|---|---|---|
| Phenol Neurolysis | Patients in this group receive ultrasound-guided genicular nerve neurolysis. Using a 22G, 50 mm needle under ultrasound guidance, injections are performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of 6% phenol is injected to achieve chemical neurolysis and long-term pain relief. Receives: Drug: Phenol Injection | |
| Local Anesthetic + Triamcinolone Acetonide Block | Patients in this group receive ultrasound-guided genicular nerve block. At the same three target nerves (superomedial, superolateral, inferomedial), 2 mL of a mixture containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected at each site. This combination provides nerve blockade with additional anti-inflammatory effect from the corticosteroid. Receives: Drug: Bupivacaine + Triamcinolone Acetonide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Pain severity will be evaluated using the Visual Analog Scale (VAS; 0-10 cm), where 0 indicates no pain and 10 indicates the worst imaginable pain. Patients will rate their knee pain at rest and during activity. The main outcome is the change in VAS score from baseline to follow-up assessments.
Measured: Baseline, 2 weeks, and 3 months after the intervention
Secondary outcomes (5)
Change in Function and Symptoms Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC Index will be used to assess three domains: pain, stiffness, and physical function in patients with knee osteoarthritis. Scores will be calculated according to the standard WOMAC scoring system, with higher scores indicating worse symptoms. The outcome is the change in WOMAC score from baseline to follow-up.
Measured: Baseline, 2 weeks, 3 months, and 6 months after the intervention
Change in Knee Function Measured by Oxford Knee Score (OKS)
he Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure evaluating pain and physical function related to the knee. Scores range from 0 to 48, with higher scores indicating better function. The outcome is the change in OKS from baseline to follow-up.
Measured: Baseline, 2 weeks, 3 months, and 6 months after the intervention
Change in Knee Range of Motion (ROM)
Knee joint range of motion, including flexion and extension, will be measured using a goniometer by a blinded assessor. Both active and passive ROM will be recorded. The outcome is the change in degrees of movement compared to baseline.
Measured: Baseline, 2 weeks, 3 months, and 6 months after the intervention
Change in Nonsteroidal Anti-inflammatory Drug (NSAID) Consumption
The number of NSAID doses consumed by participants will be recorded throughout the follow-up period. The outcome measure is the total NSAID use and change compared to baseline.
Measured: Baseline to 2 weeks, 2 weeks to 3 months, and 3 to 6 months after the intervention
Adverse Events Related to the Intervention
Any adverse events possibly or probably related to the intervention will be recorded, including local complications (infection, bleeding, hematoma, skin changes) or systemic side effects.
Measured: Baseline through 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 May 2025
- Primary completion1 Apr 2026
- Study completion1 May 2026
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 Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salim Sencar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salim Sencar, Ondokuz Mayıs University
- Investigators
- Bora UZUNER, MD (Medical Doctor), Principal investigator, Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and RehabilitationSalim SENCAR, MD (Medical Doctor), Study director, Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267039
- Sponsor's protocol ID
- OMU-FTR-2025/44
- Other IDs
- OMU-EC-2025-44
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center thesis study with a small number of patients, and data are not intended for public repositories. Only aggregated, anonymized results will be published.
Publications
Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.
PubMed 33277760Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
PubMed 36369781
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phenol Neurolysis and Local Anesthetic Plus Steroid Genicular Nerve Block Under Ultrasound Guidance in Patients With Knee Osteoarthritis: Effects on Pain, Function, and Safety
- ClinicalTrials.gov ID
- NCT07267039
- Acronym / sponsor ID
- OMU-FTR-2025/44
- Conditions
- Knee Osteoarthritis, Genicular Nerve Block
- Keywords
- Knee Osteoarthritis, Gonarthrosis, Genicular Nerve Block, Genicular Nerve Neurolysis, Phenol, Bupivacaine, Triamcinolone Acetonide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Salim SencarUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 5 Dec 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 aims to evaluate two different ultrasound-guided procedures for patients with knee osteoarthritis (gonarthrosis) who did not benefit from conservative treatments. The first method is genicular nerve neurolysis with phenol, a chemical agent that blocks nerve signals and may reduce pain for a longer period. The second method is a genicular nerve block with local anesthetic (bupivacaine) and corticosteroid (triamcinolone acetonide), which is commonly used to relieve pain and inflammation.
A total of 42 patients are followed prospectively. Pain intensity is measured using the Visual Analog Scale (VAS), and functional outcomes are assessed with the WOMAC Index and Oxford Knee Score (OKS). Joint range of motion, need for pain medications, and possible side effects are also monitored.
The results will help to compare the effectiveness and safety of phenol neurolysis and triamcinolone acetonide-local anesthetic nerve block, and may guide future treatment choices for patients with knee osteoarthritis.
Detailed description
Knee osteoarthritis (gonarthrosis) is a major cause of chronic pain and disability. Patients who fail to respond to conservative treatments such as medications, physical therapy, and exercise often require interventional options for pain relief.
This prospective observational cohort study compares two ultrasound-guided procedures targeting the genicular nerves of the knee:
Genicular nerve neurolysis with phenol - phenol induces protein denaturation and Wallerian degeneration in nerve fibers, providing long-term analgesia.
Genicular nerve block with local anesthetic (bupivacaine) and corticosteroid (triamcinolone acetonide) - this combination offers immediate pain reduction from nerve blockade and potential prolonged relief due to the anti-inflammatory action of the steroid.
A total of 42 patients with Kellgren-Lawrence grade 3-4 knee osteoarthritis and moderate-to-severe pain (VAS ≥ 4 for ≥ 3 months) are prospectively followed. Interventions are performed under ultrasound guidance at the superomedial, superolateral, and inferomedial genicular nerves.
The primary outcome is change in pain severity (VAS). Secondary outcomes include functional improvement assessed by the WOMAC Index and Oxford Knee Score (OKS), joint range of motion, need for nonsteroidal anti-inflammatory drugs (NSAIDs), and procedure-related adverse events. Assessments are performed at baseline, 2 weeks, and 3 months post-procedure.
The study aims to provide comparative evidence on the effectiveness and safety of phenol neurolysis versus triamcinolone acetonide-local anesthetic block, helping to guide clinical practice in the management of knee osteoarthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenol Neurolysis | – | Drug: Phenol InjectionPatients in this group receive ultrasound-guided genicular nerve neurolysis. Using a 22G, 50 mm needle under ultrasound guidance, injections are performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of 6% phenol is injected to achieve chemical neurolysis and long-term pain relief. |
| Local Anesthetic + Triamcinolone Acetonide Block | – | Drug: Bupivacaine + Triamcinolone Acetonide InjectionPatients in this group receive ultrasound-guided genicular nerve block. At the same three target nerves (superomedial, superolateral, inferomedial), 2 mL of a mixture containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected at each site. This combination provides nerve blockade with additional anti-inflammatory effect from the corticosteroid. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥40 years) diagnosed with moderate to severe knee osteoarthritis (Kellgren-Lawrence grade 3-4) who did not benefit from conservative treatments such as medications and physical therapy. A total of 42 patients are enrolled and treated at the Physical Medicine and Rehabilitation Department, Ondokuz Mayis University, Faculty of Medicine, Samsun, Turkey.
Key inclusion criteria (5 listed)
- Age ≥ 40 years
- Diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 3-4) confirmed by radiographic evaluation
- Moderate to severe knee pain for at least 3 months (VAS ≥ 4)
- Inadequate response to conservative treatments (e.g., medications, physical therapy, exercise)
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- History of knee surgery (e.g., total knee arthroplasty) on the affected side
- Intra-articular injection (hyaluronic acid, corticosteroid, PRP, etc.) within the last 6 months
- Secondary arthritis (e.g., rheumatoid arthritis, gout, septic arthritis, trauma-related arthritis)
- Severe coagulopathy or current use of anticoagulant therapy contraindicating injection
- Local skin infection at the injection site
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 |
|---|---|---|
| Phenol InjectionAlso: Phenol NeurolysisUltrasound-guided genicular nerve neurolysis performed at the superomedial, superolateral, and inferomedial genicular nerves. A 22G, 50 mm insulated needle is placed under ultrasound guidance, and 2 mL of 6% phenol is injected at each target site for chemical neurolysis. | Drug | Phenol Neurolysis |
| Bupivacaine + Triamcinolone Acetonide InjectionAlso: Local Anesthetic + Steroid BlockUltrasound-guided genicular nerve block performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of a solution containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected using a 22G, 50 mm insulated needle. This provides both local anesthetic and anti-inflammatory effects. | Drug | Local Anesthetic + Triamcinolone Acetonide Block |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline, 2 weeks, and 3 months after the intervention
Pain severity will be evaluated using the Visual Analog Scale (VAS; 0-10 cm), where 0 indicates no pain and 10 indicates the worst imaginable pain. Patients will rate their knee pain at rest and during activity. The main outcome is the change in VAS score from baseline to follow-up assessments.
5 secondary outcomes
Change in Function and Symptoms Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 2 weeks, 3 months, and 6 months after the intervention
Change in Knee Function Measured by Oxford Knee Score (OKS)
Time frame: Baseline, 2 weeks, 3 months, and 6 months after the intervention
Change in Knee Range of Motion (ROM)
Time frame: Baseline, 2 weeks, 3 months, and 6 months after the intervention
Change in Nonsteroidal Anti-inflammatory Drug (NSAID) Consumption
Time frame: Baseline to 2 weeks, 2 weeks to 3 months, and 3 to 6 months after the intervention
Adverse Events Related to the Intervention
Time frame: Baseline through 6 months after the intervention
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 18 Aug 2026.
- Results publication: PubMed 33277760Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.
- Results publication: PubMed 36369781Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
- American College of Rheumatology (ACR) Guideline for the Management of Osteoarthritis of the KneeLink provided by the sponsor.
- National Institute for Health and Care Excellence (NICE) Guideline for Osteoarthritis: Care and ManagementLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center thesis study with a small number of patients, and data are not intended for public repositories. Only aggregated, anonymized results will be published.
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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.
Bora UZUNER, MD (Medical Doctor) principal investigator
Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Salim SENCAR, MD (Medical Doctor) study director
Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Genicular Nerve Block, run by Salim Sencar 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 5 inclusion and 8 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 18 Aug 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?
Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline, 2 weeks, and 3 months after the intervention). 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 NCT07267039, 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 18 Aug 2026.