Joint PainNCT06864390
Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis
A study testing genicular nerve neurolysis in people with Joint Pain, run by Ain Shams University.
Trial summary
The goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Joint Pain
- What is being tested?
- genicular nerve neurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Grade 4 knee osteoarthritis according to Kellgren-Lawrence radiological classification.
- Failure to manage pain with conservative methods.
Who cannot join
- Prior knee replacement
- Patients with cardiac pacemakers or implantable cardiac defibrillators.
- Septic knee or systemic sepsis.
- Allergy to any of the drugs used in the study.
- Coagulopathy or patients on anticoagulants.
- Patients with psychiatric illness.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score.
The participants will be evaluated by numeric rating scale and oxford knee score for assessment of pain relief up to 16 weeks.
- Conditions
- Joint Pain
- Being tested
- genicular nerve neurolysis
- Keywords
- phenol neurolysis, radiofrequency, Knee osteoarthritis
- Medical subject headings
- Arthralgia, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve neurolysisProcedure or surgery
The superior medial genicular nerve (SMGN), superior lateral genicular nerve (SLGN), and inferior medial genicular nerve (IMGN) will be blocked either by phenol neurolysis or radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| genicular nerve phenol neurolysis | Experimental | chemical neurolysis using 2 mL of 9% phenol solution prepared from crystallized phenol will be applied to each genicular nerve. Receives: Procedure: genicular nerve neurolysis |
| genicular nerve radiofrequency ablation | Experimental | Radiofrequency thermocoagulation will be applied to each nerve at 80 degrees for 90 seconds. Receives: Procedure: genicular nerve neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale
By an independent physician pain will be recorded using numeric rating scale which is a screening tool used to assess pain severity using a 0 - 10 scale with zero meaning no pain and 10 meaning the worst pain ever.
Measured: baseline, 2, 4, 8,12 and 16 weeks after the procedure
Secondary outcomes (1)
oxford knee score
This score is used to assess both function and pain of the knee on a scale ranging from 0 (worst pain and function) and 48 (best function and no pain) this score will be recorded by an independent physician
Measured: baseline, 4, 8, 12, 16 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Boeith, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864390
- Sponsor's protocol ID
- FMASU R17/2025
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06864390
- Acronym / sponsor ID
- FMASU R17/2025
- Conditions
- Joint Pain
- Keywords
- phenol neurolysis, radiofrequency, Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 7 Mar 2025 (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 goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score.
The participants will be evaluated by numeric rating scale and oxford knee score for assessment of pain relief up to 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| genicular nerve phenol neurolysis | Experimental | Procedure: genicular nerve neurolysischemical neurolysis using 2 mL of 9% phenol solution prepared from crystallized phenol will be applied to each genicular nerve. |
| genicular nerve radiofrequency ablation | Experimental | Procedure: genicular nerve neurolysisRadiofrequency thermocoagulation will be applied to each nerve at 80 degrees for 90 seconds. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Grade 4 knee osteoarthritis according to Kellgren-Lawrence radiological classification.
- Failure to manage pain with conservative methods.
Key exclusion criteria (6 listed)
- Prior knee replacement
- Patients with cardiac pacemakers or implantable cardiac defibrillators.
- Septic knee or systemic sepsis.
- Allergy to any of the drugs used in the study.
- Coagulopathy or patients on anticoagulants.
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 neurolysisThe superior medial genicular nerve (SMGN), superior lateral genicular nerve (SLGN), and inferior medial genicular nerve (IMGN) will be blocked either by phenol neurolysis or radiofrequency ablation | Procedure or surgery | genicular nerve phenol neurolysis, genicular nerve radiofrequency ablation |
Primary outcome
Numeric rating scale
Time frame: baseline, 2, 4, 8,12 and 16 weeks after the procedure
By an independent physician pain will be recorded using numeric rating scale which is a screening tool used to assess pain severity using a 0 - 10 scale with zero meaning no pain and 10 meaning the worst pain ever.
1 secondary outcome
oxford knee score
Time frame: baseline, 4, 8, 12, 16 weeks after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
Ahmed Boeith, MD principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing genicular nerve neurolysis in people with Joint Pain, run by Ain Shams University.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed boeith, MD (02001003074795, ahmedabdelrahamn2008@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (time frame: baseline, 2, 4, 8,12 and 16 weeks after the procedure). 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 7 Mar 2025.