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CompletedNCT06087601Updated Jan 21, 2025

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

A Phase 4 interventional study of 0.9% Sodium chloride and 95% ethanol in Osteo Arthritis Knee and Osteoarthritis, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-01-21.

Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Osteo Arthritis Knee
  • Osteoarthritis
03

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • suspected or diagnosed opioid dependence syndrome
  • active cancer
  • dementia
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Sham blocks

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

    Drug: 0.9% Sodium chloride

  • Active comparator
    Genicular nerve neurolysis

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

    Drug: 95% ethanol

Interventions

  • Drug0.9% Sodium chloride

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

    Also known as: Sham block

  • Drug95% ethanol

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

    Also known as: neurolisis

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: 7 days after procedure

  2. 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"

    Time frame: 30 days after procedure

  3. 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"

    Time frame: 3 months after procedure

  4. 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"

    Time frame: 6 months after procedure

Secondary outcomes

  1. 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.

    Time frame: 7 days after surgery

  2. 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.

    Time frame: 30 days after surgery

  3. 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.

    Time frame: 3 months after surgery

  4. 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.

    Time frame: 6 months after surgery

  5. neurological deficits

    yes/no

    Time frame: 7 days after procedures

  6. neurological deficits

    yes/no

    Time frame: 30 days after procedures

  7. neurological deficits

    yes/no

    Time frame: 3 months after procedures

  8. neurological deficits

    yes/no

    Time frame: 6 months after procedures

  9. total opioid consumption

    milligrams of oral morphine per day

    Time frame: 7 days after procedure

  10. total opioid consumption

    milligrams of oral morphine per day

    Time frame: 30 days after procedure

  11. total opioid consumption

    milligrams of oral morphine per day

    Time frame: 3 months after procedure

  12. total opioid consumption

    milligrams of oral morphine per day

    Time frame: 6 months after procedure

07

Study locations

1 site
  • Poznan University of Medical Sciences
    Poznan, Poznań 61-701, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06087601
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Sponsor
First posted
Oct 18, 2023
Start date
Oct 17, 2023
Primary completion
Jan 10, 2025
Completion
Jan 14, 2025
Last update
Jan 21, 2025

Study contacts

Katarzyna Wieczorowska-Tobis, Prof.dr hab
study director · Poznań University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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