Osteo Arthritis KneePhase 4NCT06087601
The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients with Advanced Knee Osteoarthritis.
A Phase 4 study testing 0.9% Sodium chloride and 95% ethanol in people with Osteo Arthritis Knee and Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Osteo Arthritis Knee, Osteoarthritis
- What is being tested?
- 0.9% Sodium chloride and 95% ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 17 Oct 2023to 14 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- suspected or diagnosed opioid dependence syndrome
- active cancer
- dementia
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Osteo Arthritis Knee, Osteoarthritis
- Being tested
- 0.9% Sodium chloride, 95% ethanol
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium chlorideDrug
Also called Sham block
us-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline
95% ethanolDrug
Also called neurolisis
us-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol
| Study group | Role | What they receive |
|---|---|---|
| Sham blocks | Active comparator | US-guided Bilateral genicular nerve block with 0,9% NaCl Receives: Drug: 0.9% Sodium chloride |
| Genicular nerve neurolysis | Active comparator | US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol Receives: Drug: 95% ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 6 months after procedure
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after surgery
neurological deficits
yes/no
Measured: 7 days after procedures
neurological deficits
yes/no
Measured: 30 days after procedures
neurological deficits
yes/no
Measured: 3 months after procedures
neurological deficits
yes/no
Measured: 6 months after procedures
total opioid consumption
milligrams of oral morphine per day
Measured: 7 days after procedure
total opioid consumption
milligrams of oral morphine per day
Measured: 30 days after procedure
total opioid consumption
milligrams of oral morphine per day
Measured: 3 months after procedure
total opioid consumption
milligrams of oral morphine per day
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start17 Oct 2023
- Primary completion10 Jan 2025
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: sham blocks Group 2: genicular nerve neurolysis
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Wieczorowska-Tobis, Prof.dr hab, Study director, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087601
- Sponsor's protocol ID
- 6/2023
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2023
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06087601
- Acronym / sponsor ID
- 6/2023
- Conditions
- Osteo Arthritis Knee, Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: sham blocks Group 2: genicular nerve neurolysis
| Arm | Type | Receives |
|---|---|---|
| Sham blocks | Active comparator | Drug: 0.9% Sodium chlorideUS-guided Bilateral genicular nerve block with 0,9% NaCl |
| Genicular nerve neurolysis | Active comparator | Drug: 95% ethanolUS-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- suspected or diagnosed opioid dependence syndrome
- active cancer
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% Sodium chlorideAlso: Sham blockus-guided bilateral genicular nerves sham block with 0,5ml 0,9% normal saline | Drug | Sham blocks |
| 95% ethanolAlso: neurolisisus-guided bilateral genicular nerves neurolysis with 0,5ml 95% ethanol | Drug | Genicular nerve neurolysis |
Primary outcome
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"
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"
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"
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"
12 secondary outcomes
Health Questionnaire (EQ-5D-5L)
Time frame: 7 days after surgery
Health Questionnaire (EQ-5D-5L)
Time frame: 30 days after surgery
Health Questionnaire (EQ-5D-5L)
Time frame: 3 months after surgery
Health Questionnaire (EQ-5D-5L)
Time frame: 6 months after surgery
neurological deficits
Time frame: 7 days after procedures
neurological deficits
Time frame: 30 days after procedures
neurological deficits
Time frame: 3 months after procedures
neurological deficits
Time frame: 6 months after procedures
total opioid consumption
Time frame: 7 days after procedure
total opioid consumption
Time frame: 30 days after procedure
total opioid consumption
Time frame: 3 months after procedure
total opioid consumption
Time frame: 6 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Wieczorowska-Tobis, Prof.dr hab study director
Poznań University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9% Sodium chloride and 95% ethanol in people with Osteo Arthritis Knee and Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: 7 days after procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.