Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Samsun, 55139, Turkey (Türkiye)
NCT Number: NCT07267039
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.
This study is active but is not currently recruiting participants.
Notify Me40 year and older
All sexes
Observational
Samsun, 55139, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: 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.
Other names: Local Anesthetic + Steroid Block
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.
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.
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.
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.
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.
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.
Salim Sencar
Other
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
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