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Completed

NCT Number: NCT06087601

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

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

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% Sodium Chloride

Drug

us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline

Other names: Sham block

95% ethanol

Drug

us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol

Other names: neurolisis

Primary outcomes

  1. NRS

    Time frame: 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"

  2. NRS

    Time frame: 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"

  3. NRS

    Time frame: 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"

  4. NRS

    Time frame: 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 outcomes

  1. Health Questionnaire (EQ-5D-5L)

    Time frame: 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.

  2. Health Questionnaire (EQ-5D-5L)

    Time frame: 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.

  3. Health Questionnaire (EQ-5D-5L)

    Time frame: 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.

  4. Health Questionnaire (EQ-5D-5L)

    Time frame: 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.

  5. neurological deficits

    Time frame: 7 days after procedures

    yes/no

  6. neurological deficits

    Time frame: 30 days after procedures

    yes/no

  7. neurological deficits

    Time frame: 3 months after procedures

    yes/no

  8. neurological deficits

    Time frame: 6 months after procedures

    yes/no

  9. total opioid consumption

    Time frame: 7 days after procedure

    milligrams of oral morphine per day

  10. total opioid consumption

    Time frame: 30 days after procedure

    milligrams of oral morphine per day

  11. total opioid consumption

    Time frame: 3 months after procedure

    milligrams of oral morphine per day

  12. total opioid consumption

    Time frame: 6 months after procedure

    milligrams of oral morphine per day

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2023
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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