The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients With Advanced Knee Osteoarthritis.
Study Details
Study Description
Brief Summary
Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sham blocks US-guided Bilateral genicular nerve block with 0,9% NaCl |
Drug: 0.9% Sodium chloride
us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline
Other Names:
|
| Active Comparator: Genicular nerve neurolysis US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol |
Drug: 95% ethanol
us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol
Other Names:
|
Outcome Measures
Primary Outcome Measures
- NRS [7 days 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"
- NRS [30 days 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"
- NRS [3 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"
- 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
- Health Questionnaire (EQ-5D-5L) [7 days 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.
- Health Questionnaire (EQ-5D-5L) [30 days 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.
- Health Questionnaire (EQ-5D-5L) [3 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.
- 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 [7 days after procedures]
yes/no
- neurological deficits [30 days after procedures]
yes/no
- neurological deficits [3 months after procedures]
yes/no
- neurological deficits [6 months after procedures]
yes/no
- total opioid consumption [7 days after procedure]
milligrams of oral morphine per day
- total opioid consumption [30 days after procedure]
milligrams of oral morphine per day
- total opioid consumption [3 months after procedure]
milligrams of oral morphine per day
- total opioid consumption [6 months after procedure]
milligrams of oral morphine per day
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Poznan University of Medical Sciences
Investigators
- Study Director: Katarzyna Wieczorowska-Tobis, Prof.dr hab, Poznań University of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6/2023