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Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham blocks | Active Comparator | US-guided Bilateral genicular nerve block with 0,9% NaCl |
|
| Genicular nerve neurolysis | Active Comparator | US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% Sodium chloride | Drug | us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Wieczorowska-Tobis, Prof.dr hab | Poznań University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | Poznań | 61-701 | Poland |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Group 1: sham blocks Group 2: genicular nerve neurolysis
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| 95% ethanol | Drug | us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol |
|
|
| 7 days after surgery |
| 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 |
| 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 |
| 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 |
| neurological deficits | yes/no | 7 days after procedures |
| neurological deficits | yes/no | 30 days after procedures |
| neurological deficits | yes/no | 3 months after procedures |
| neurological deficits | yes/no | 6 months after procedures |
| total opioid consumption | milligrams of oral morphine per day | 7 days after procedure |
| total opioid consumption | milligrams of oral morphine per day | 30 days after procedure |
| total opioid consumption | milligrams of oral morphine per day | 3 months after procedure |
| total opioid consumption | milligrams of oral morphine per day | 6 months after procedure |
| D017670 |
| Sodium Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |