NCT07267039

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 5, 2025

Status Verified

October 1, 2025

Enrollment Period

4 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

Knee OsteoarthritisGonarthrosisGenicular Nerve BlockGenicular Nerve NeurolysisPhenolBupivacaineTriamcinolone Acetonide

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    Baseline, 2 weeks, 3 months, and 6 months after the intervention

  • Change in Knee Function Measured by Oxford Knee Score (OKS)

    Baseline, 2 weeks, 3 months, and 6 months after the intervention

  • Change in Knee Range of Motion (ROM)

    Baseline, 2 weeks, 3 months, and 6 months after the intervention

  • Change in Nonsteroidal Anti-inflammatory Drug (NSAID) Consumption

    Baseline to 2 weeks, 2 weeks to 3 months, and 3 to 6 months after the intervention

  • Adverse Events Related to the Intervention

    Baseline through 6 months after the intervention

Study Arms (2)

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.

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.

Drug: Bupivacaine + Triamcinolone Acetonide Injection

Interventions

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.

Also known as: Phenol Neurolysis
Phenol Neurolysis

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.

Also known as: Local Anesthetic + Steroid Block
Local Anesthetic + Triamcinolone Acetonide Block

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

PhenolBupivacaineTriamcinolone AcetonideAnesthetics, Local

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAminesTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Bora UZUNER, MD (Medical Doctor)

    Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Salim SENCAR, MD (Medical Doctor)

    Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Physician (Research Assistant), Department of Physical Medicine and Rehabilitation, Ondokuz Mayıs University Faculty of Medicine

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

May 1, 2025

Primary Completion

September 1, 2025

Study Completion

January 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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.

Locations