CryoneurolysisNCT07855367
Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis
A study testing Ultrasound-guided cryoneurolysis and Bipolar radiofrequency ablation in people with Cryoneurolysis and Bipolar Radiofrequency Ablation, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to compare the reduction in knee pain between ultrasound-guided cryoneurolysis and bipolar radiofrequency ablation (RFA), as measured by the Numerical Rating Scale (NRS) at predefined follow-up intervals. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cryoneurolysis, Bipolar Radiofrequency Ablation, Genicular Nerves
- What is being tested?
- Ultrasound-guided cryoneurolysis and Bipolar radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2026to 15 Mar 2027
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Symptomatic knee osteoarthritis (OA) in bladder cancer patient [based on American College of Radiology (ACR) criteria]
- Radiological OA (Kellgren-Lawrence grade III-IV)
- Chronic knee pain ≥ 3-6 months
- Numerical Rating Scale (NRS) ≥ 5 despite conservative treatment
- Positive diagnostic genicular nerve block (>50% pain relief).
Who cannot join
- Prior genicular nerve ablation
- Coagulopathy
- Local infection
- Severe deformity
- Neuropathic pain syndromes
- Uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Ahmed S Abdelgalil, MD, 00201098426689, ahmed.salah@nci.cu.edu.eg
About this study
Official title: Ultrasound-Guided Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial
This study aims to compare the reduction in knee pain between ultrasound-guided cryoneurolysis and bipolar radiofrequency ablation (RFA), as measured by the Numerical Rating Scale (NRS) at predefined follow-up intervals.
Read the detailed description
Knee osteoarthritis (KOA) is a major cause of chronic pain and disability worldwide. Pain in knee osteoarthritis is multifactorial and does not always correlate with the degree of radiographic degeneration. In addition to structural joint changes, pain results from synovial inflammation, subchondral bone remodeling, periosteal irritation, ligamentous stress, and sensitization of peripheral and central nociceptive pathways.
Among the available interventional approaches, radiofrequency ablation (RFA) and cryoneurolysis have gained increasing attention because they interrupt pain transmission without affecting joint stability. Radiofrequency ablation (RFA) and cryoneurolysis are two emerging techniques that modulate pain transmission pathways. Bipolar radiofrequency ablation uses thermal energy delivered between two closely positioned electrodes to create a larger and more continuous lesion than conventional monopolar RFA.
- Conditions
- Cryoneurolysis, Bipolar Radiofrequency Ablation, Genicular Nerves, Pain Relief, Symptomatic, Knee Osteoarthritis
- Being tested
- Ultrasound-guided cryoneurolysis, Bipolar radiofrequency ablation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided cryoneurolysisProcedure or surgery
Patients will undergo ultrasound-guided cryoneurolysis
Bipolar radiofrequency ablationProcedure or surgery
Patients will undergo bipolar radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis group | Experimental | Patients will undergo ultrasound-guided cryoneurolysis Receives: Procedure: Ultrasound-guided cryoneurolysis |
| Radiofrequency ablation group | Experimental | Patients will undergo bipolar radiofrequency ablation Receives: Procedure: Bipolar radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 6 months after procedure
Secondary outcomes (7)
Knee Injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score (KOOS) will measure
- Pain
- Symptoms
- Activities of daily living
- Sports/recreation
- Quality of life
Measured: 6 months after procedure
Western Ontario and McMaster Universities Osteoarthritis Index
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index is a widely used, self-administered questionnaire that evaluates pain, stiffness, and physical function in patients with knee and hip osteoarthritis.
Measured: 6 months after procedure
Oxford Knee Score
The Oxford Knee Score is a 12-item patient-reported questionnaire used to assess pain and physical function in the knee.
Score Interpretation 0 to 19 (Severe): May indicate severe knee problems or advanced arthritis; surgical intervention like a knee replacement may be considered.
20 to 29 (Moderate to Severe): Reflects considerable pain and functional limitations.
30 to 39 (Mild to Moderate): Suggests mild-to-moderate joint issues with some activity limitations.
40 to 48 (Satisfactory): Indicates normal or satisfactory joint function with minimal knee problems.
Measured: 6 months after procedure
Patient Global Impression of Change (PGIC)
The traditional Patient Global Impression of Change (PGIC) uses a 7-point scale where patients select the statement that best describes their current state compared to how they felt before treatment:
- Very much improved (or Much better)
- Much improved
- Minimally improved
- No change (or The same)
- Minimally worse
- Much worse
- Very much worse (or Very much worse)
Measured: 6 months after procedure
Measurement of quality of life
Quality of life will be assessed using EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Measured: 6 months after procedure
Total analgesic consumption
Total analgesic consumption will be recorded.
Measured: 24 hours after procedure
Incidence of complication
Incidence of complication will be recorded.
Measured: 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Sep 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryoneurolysisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855367
- Sponsor's protocol ID
- AP2609-501-213
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07855367
- Acronym / sponsor ID
- AP2609-501-213
- Conditions
- Cryoneurolysis, Bipolar Radiofrequency Ablation, Genicular Nerves, Pain Relief, Symptomatic, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
This study aims to compare the reduction in knee pain between ultrasound-guided cryoneurolysis and bipolar radiofrequency ablation (RFA), as measured by the Numerical Rating Scale (NRS) at predefined follow-up intervals.
Detailed description
Knee osteoarthritis (KOA) is a major cause of chronic pain and disability worldwide. Pain in knee osteoarthritis is multifactorial and does not always correlate with the degree of radiographic degeneration. In addition to structural joint changes, pain results from synovial inflammation, subchondral bone remodeling, periosteal irritation, ligamentous stress, and sensitization of peripheral and central nociceptive pathways.
Among the available interventional approaches, radiofrequency ablation (RFA) and cryoneurolysis have gained increasing attention because they interrupt pain transmission without affecting joint stability. Radiofrequency ablation (RFA) and cryoneurolysis are two emerging techniques that modulate pain transmission pathways. Bipolar radiofrequency ablation uses thermal energy delivered between two closely positioned electrodes to create a larger and more continuous lesion than conventional monopolar RFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis group | Experimental | Procedure: Ultrasound-guided cryoneurolysisPatients will undergo ultrasound-guided cryoneurolysis |
| Radiofrequency ablation group | Experimental | Procedure: Bipolar radiofrequency ablationPatients will undergo bipolar radiofrequency ablation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 40 years
- Symptomatic knee osteoarthritis (OA) in bladder cancer patient [based on American College of Radiology (ACR) criteria]
- Radiological OA (Kellgren-Lawrence grade III-IV)
- Chronic knee pain ≥ 3-6 months
- Numerical Rating Scale (NRS) ≥ 5 despite conservative treatment
Key exclusion criteria (6 listed)
- Prior genicular nerve ablation
- Coagulopathy
- Local infection
- Severe deformity
- Neuropathic pain syndromes
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 |
|---|---|---|
| Ultrasound-guided cryoneurolysisPatients will undergo ultrasound-guided cryoneurolysis | Procedure or surgery | Cryoneurolysis group |
| Bipolar radiofrequency ablationPatients will undergo bipolar radiofrequency ablation | Procedure or surgery | Radiofrequency ablation group |
Primary outcome
Degree of pain
Time frame: 6 months after procedure
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
7 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 months after procedure
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 6 months after procedure
Oxford Knee Score
Time frame: 6 months after procedure
Patient Global Impression of Change (PGIC)
Time frame: 6 months after procedure
Measurement of quality of life
Time frame: 6 months after procedure
Total analgesic consumption
Time frame: 24 hours after procedure
Incidence of complication
Time frame: 24 hours after 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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided cryoneurolysis and Bipolar radiofrequency ablation in people with Cryoneurolysis and Bipolar Radiofrequency Ablation, run by National Cancer Institute, Egypt 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 6 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
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 S Abdelgalil, MD (00201098426689, ahmed.salah@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 6 months after 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 2 Oct 2026.