Knee OsteoarthritisNCT05980338
Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis
A study testing genicular nerve ablation by thermal radiofrequency and genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis in people with Knee Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
Trial summary
the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- genicular nerve ablation by thermal radiofrequency and genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jun 2023to Nov 2023
- Phase
- Interventional
- 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders.
- Age between 60-70 years.
- ASA 1,2 \& 3 physical status.
- x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery
Who cannot join
- Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
- coagulopathy ( plt < 50000, INR > 1.7 )
- Infection at or near the injection site.
- presence of pacemaker or defibrillator 5 - Acute knee injury.
- 6- age < 60 or >70 years
Trial locations and contacts
1 site in 1 country.
samuel H Daniel, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
lydia E zakhary, 01222555128, lydia_zakhary@med.asu.edu.eg
About this study
Official title: Comparative Study Between Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis for Treatment of Symptomatic Knee Osteoarthritis
the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.
- Conditions
- Knee Osteoarthritis
- Being tested
- genicular nerve ablation by thermal radiofrequency, genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve ablation by thermal radiofrequencyProcedure or surgery
radio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ) .
A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radiofrequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view separated by 0,5 cm to ensure successful targeting. Then remove the needles.
genicular nerve ablation by thermal radiofrequency plus alcohol neurolysisProcedure or surgery
radio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves of the knee.
A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radio-frequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view. After the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve Then remove the needles.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The patients are placed in supine position with knee preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radio frequency machine will be placed in the other leg (we used the Neurotherm NT1100 re generator) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ). this group will receive radio frequency alone . Receives: Procedure: genicular nerve ablation by thermal radiofrequency |
| study group | Experimental | this group will pass through the all steps but after the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve. Receives: Procedure: genicular nerve ablation by thermal radiofrequency; Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief after 1 month
evaluating degree of pain relief after knee genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis using numeric pain rating scale ( 11 number score scale where 0 indicates no pain and 10 indicates worst pain imaginable )after 1 month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start17 Jun 2023
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia edward aziz zakhary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980338
- Sponsor's protocol ID
- knee genicular nerve ablation
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
PubMed 31333900Liu J, Wang T, Zhu ZH. Efficacy and safety of radiofrequency treatment for improving knee pain and function in knee osteoarthritis: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Jan 15;17(1):21. doi: 10.1186/s13018-021-02906-4.
PubMed 35033150Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.
PubMed 31257831
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis for Treatment of Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05980338
- Acronym / sponsor ID
- knee genicular nerve ablation
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Jun 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 8 Aug 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.
the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: genicular nerve ablation by thermal radiofrequencyThe patients are placed in supine position with knee preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radio frequency machine will be placed in the other leg (we used the Neurotherm NT1100 re generator) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ). this group will receive radio frequency alone . |
| study group | Experimental | Procedure: genicular nerve ablation by thermal radiofrequency, Procedure: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysisthis group will pass through the all steps but after the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders.
- Age between 60-70 years.
- ASA 1,2 \& 3 physical status.
- x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery
Key exclusion criteria (5 listed)
- Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
- coagulopathy ( plt < 50000, INR > 1.7 )
- Infection at or near the injection site.
- presence of pacemaker or defibrillator 5 - Acute knee injury.
- 6- age < 60 or >70 years
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 |
|---|---|---|
| genicular nerve ablation by thermal radiofrequencyradio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ) . A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radiofrequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view separated by 0,5 cm to ensure successful targeting. Then remove the needles. | Procedure or surgery | control group, study group |
| genicular nerve ablation by thermal radiofrequency plus alcohol neurolysisradio-frequency will be done using the Neurotherm NT1100 re-generator. The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves of the knee. A confirmation of the targeted sites is done under fluoroscopy in both A-P and lateral views then a motor stimulation will be done to ensure no undesirable motor response followed by lidocaine 1 % injection and placing of the radio-frequency cables and ablation was done at 80 degrees for 90 seconds . The procedure will be repeated 3 times at different levels in the lateral view. After the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve Then remove the needles. | Procedure or surgery | study group |
Primary outcome
pain relief after 1 month
Time frame: 1 month
evaluating degree of pain relief after knee genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis using numeric pain rating scale ( 11 number score scale where 0 indicates no pain and 10 indicates worst pain imaginable )after 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 31333900Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
- Background: PubMed 35033150Liu J, Wang T, Zhu ZH. Efficacy and safety of radiofrequency treatment for improving knee pain and function in knee osteoarthritis: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Jan 15;17(1):21. doi: 10.1186/s13018-021-02906-4.
- Background: PubMed 31257831Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.
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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.
samuel H Daniel, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genicular nerve ablation by thermal radiofrequency and genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis in people with Knee Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. 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 Egypt. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lydia E Zakhary, MD (00201222555128, lydia_zakhary@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief after 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980338, which also lists 3 linked publications.
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 8 Aug 2023.