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

Osteoarthritis Clinical Trial

Official title:

The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients With Advanced Knee Osteoarthritis. A Randomized, Double-blinded, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087601
• Other study ID #: 6/2023
• Status: Recruiting
• Phase: Phase 4
• Start date: October 17, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: March 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: 0048 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 28, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznan 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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 0.9% Sodium chloride
us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline
• 95% ethanol
us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS	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"	7 days after procedure
Primary	NRS	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"	30 days after procedure
Primary	NRS	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"	3 months after procedure
Primary	NRS	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"	6 months after procedure
Secondary	Health Questionnaire (EQ-5D-5L)	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.	7 days after surgery
Secondary	Health Questionnaire (EQ-5D-5L)	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.	30 days after surgery
Secondary	Health Questionnaire (EQ-5D-5L)	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.	3 months after surgery
Secondary	Health Questionnaire (EQ-5D-5L)	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.	6 months after surgery
Secondary	neurological deficits	yes/no	7 days after procedures
Secondary	neurological deficits	yes/no	30 days after procedures
Secondary	neurological deficits	yes/no	3 months after procedures
Secondary	neurological deficits	yes/no	6 months after procedures
Secondary	total opioid consumption	milligrams of oral morphine per day	7 days after procedure
Secondary	total opioid consumption	milligrams of oral morphine per day	30 days after procedure
Secondary	total opioid consumption	milligrams of oral morphine per day	3 months after procedure
Secondary	total opioid consumption	milligrams of oral morphine per day	6 months after procedure