Osteo Arthritis Knee, Osteoarthritis
Conditions
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.
Interventions
DRUG0.9% Sodium chloride
us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline
DRUG95% ethanol
us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Group 1: sham blocks Group 2: genicular nerve neurolysis
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| neurological deficits | 7 days after procedures | yes/no |
| total opioid consumption | 7 days after procedure | milligrams of oral morphine per day |
Countries
Poland
Outcome results
None listed