The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients with Advanced Knee Osteoarthritis.

Phase 4

Completed

• Conditions: Osteo Arthritis Knee; Osteoarthritis
• Interventions: Drug: 0.9% Sodium chloride; Drug: 95% ethanol

• Registration Number: NCT06087601
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.

Detailed Description

The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the knee joint.

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-10-11
• Study Start: 2023-10-17
• Study First Posted: 2023-10-18
• Status Verified: 2024-03
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-14
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
• patients with gonarthrosis who failed to achieve satisfactory pain control (NRS>3) despite the use of NSAIDs, Paracetamol, and co-analgesics
• Age of patients: from 18 to 110 years of age.
• Caucasian patients can give informed, complete, written consent.

Exclusion Criteria

• suspected or diagnosed opioid dependence syndrome
• active cancer
• dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham blocks	0.9% Sodium chloride	US-guided Bilateral genicular nerve block with 0,9% NaCl
Genicular nerve neurolysis	95% ethanol	US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol

Primary Outcome Measures

Name	Time	Method
NRS	6 months after procedure	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
Health Questionnaire (EQ-5D-5L)	6 months after surgery	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
neurological deficits	6 months after procedures	yes/no
total opioid consumption	6 months after procedure	milligrams of oral morphine per day

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland