- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267039
Phenol Neurolysis Versus Local Anesthetic Plus Steroid Genicular Nerve Block in Knee Osteoarthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Samsun, Turkey (Türkiye), 55139
- Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
|
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 2 weeks, and 3 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline through 6 months after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bora UZUNER, MD (Medical Doctor), Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
- Study Director: Salim SENCAR, MD (Medical Doctor), Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Publications and helpful links
General Publications
- Shanahan 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Organic Chemicals
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Anilides
- Amides
- Aniline Compounds
- Amines
- Triamcinolone
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Phenols
- Benzene Derivatives
- Central Nervous System Agents
- Bupivacaine
- Anesthetics, Local
- Triamcinolone Acetonide
- Phenol
Other Study ID Numbers
- OMU-FTR-2025/44
- OMU-EC-2025-44 (Other Identifier: Ondokuz Mayıs University Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
Clinical Trials on Phenol Injection
-
Mansoura UniversityUnknownExcessive Sweating of the HandsEgypt
-
King Edward Medical UniversityCompletedRectal ProlapsePakistan
-
Marmara UniversityNot yet recruitingCoccygodynia | CoccydyniaTurkey
-
Mustafa AzizoğluNecmi Kadıoğlu HospitalRecruitingPilonidal Sinus | Pilonidal DiseaseTurkey
-
Vanderbilt University Medical CenterNot yet recruitingInflammation | High Blood Pressure | Renin-Angiotensin-Aldosterone System | Salt Sensitivity of Blood PressureUnited States
-
Heinrich-Heine University, DuesseldorfCompleted
-
Vanderbilt University Medical CenterNational Institutes of Health (NIH)Not yet recruitingPulmonary Arterial Hypertension
-
Kessler FoundationRecruitingOsteoarthritis, Knee | Knee Pain ChronicUnited States
-
Assiut UniversityNot yet recruitingSpasticity as Sequela of Stroke
-
The Miriam HospitalNot yet recruitingHyperlipidemia | Elevated Lp(a)United States