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

Primary Purpose

Osteo Arthritis Knee, Osteoarthritis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.9% Sodium chloride
95% ethanol
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sham blocks

    Genicular nerve neurolysis

    Arm Description

    US-guided Bilateral genicular nerve block with 0,9% NaCl

    US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol

    Outcomes

    Primary Outcome Measures

    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"
    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"
    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"
    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"

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    neurological deficits
    yes/no
    neurological deficits
    yes/no
    neurological deficits
    yes/no
    neurological deficits
    yes/no
    total opioid consumption
    milligrams of oral morphine per day
    total opioid consumption
    milligrams of oral morphine per day
    total opioid consumption
    milligrams of oral morphine per day
    total opioid consumption
    milligrams of oral morphine per day

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Poznan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06087601
    Brief Title
    The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients With Advanced Knee Osteoarthritis.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poznan University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee, Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1: sham blocks Group 2: genicular nerve neurolysis
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham blocks
    Arm Type
    Active Comparator
    Arm Description
    US-guided Bilateral genicular nerve block with 0,9% NaCl
    Arm Title
    Genicular nerve neurolysis
    Arm Type
    Active Comparator
    Arm Description
    US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% Sodium chloride
    Other Intervention Name(s)
    Sham block
    Intervention Description
    us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    95% ethanol
    Other Intervention Name(s)
    neurolisis
    Intervention Description
    us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol
    Primary Outcome Measure Information:
    Title
    NRS
    Description
    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"
    Time Frame
    7 days after procedure
    Title
    NRS
    Description
    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"
    Time Frame
    30 days after procedure
    Title
    NRS
    Description
    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"
    Time Frame
    3 months after procedure
    Title
    NRS
    Description
    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"
    Time Frame
    6 months after procedure
    Secondary Outcome Measure Information:
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    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.
    Time Frame
    7 days after surgery
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    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.
    Time Frame
    30 days after surgery
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    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.
    Time Frame
    3 months after surgery
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    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.
    Time Frame
    6 months after surgery
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    7 days after procedures
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    30 days after procedures
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    3 months after procedures
    Title
    neurological deficits
    Description
    yes/no
    Time Frame
    6 months after procedures
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    7 days after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    30 days after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    3 months after procedure
    Title
    total opioid consumption
    Description
    milligrams of oral morphine per day
    Time Frame
    6 months after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    110 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Małgorzata Domagalska, Ph.D.
    Phone
    0048 608762068
    Email
    m.domagalska@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katarzyna Wieczorowska-Tobis, Prof.dr hab
    Organizational Affiliation
    Poznań University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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