Knee OsteoarthritisNCT07664371
Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis
A study testing Cryoneurolysis, pulsed radiofrequency (RF) and cooled radiofrequency in people with Knee Osteoarthritis, run by Tanta University at 1 site in Egypt.
Trial summary
The project will evaluate the effectiveness of Cryoneurolysis versus radiofrequency procedures in adult patients who are resistant to traditional treatment for knee pain. They are a drug-free pain management procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cryoneurolysis, pulsed radiofrequency (RF) and cooled radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2026to Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a clinical diagnosis of refractory knee OA who suffered from refractory knee pain (patients who had failed conservative medical and physical therapy for 6 months .
Who cannot join
- Patients with OA show improvement in pain after conservative medical and physical therapy.
- Patients evaluated by an orthopedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
- Patients with allergies to local anesthetics.
- patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
- Patients with knee tumors.
- Patients with acute infections.
- Patients with implanted cardiac devices.
- Pregnant patients.
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
Faculty of medicine, Tanta University
Tanta
Aliaa Mamdouh Abdelaziz Farag, MD, +201069468486, aliaa.mamdouh@med.tanta.edu.eg
About this study
Official title: Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis: A Randomised Controlled Trial
The project will evaluate the effectiveness of Cryoneurolysis versus radiofrequency procedures in adult patients who are resistant to traditional treatment for knee pain. They are a drug-free pain management procedure.
Read the detailed description
The main approach to OA management is pain control. Cryoneurolysis versus radiofrequency in decreasing knee pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cryoneurolysis, pulsed radiofrequency (RF), cooled radiofrequency
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisDevice
Cryoneurolysis freezes nerves
pulsed radiofrequency (RF)Device
radiofrequency (RF) uses electric pulses
cooled radiofrequencyDevice
uses cooled radiofrequency energy to deactivate pain-causing nerves
| Study group | Role | What they receive |
|---|---|---|
| Group I will be treated with Cryoneurolysis | Experimental | Cryoneurolysis freezes nerves Receives: Device: Cryoneurolysis |
| Group II will be treated with pulsed radiofrequency (RF) | Experimental | radiofrequency (RF) uses electric pulses Receives: Device: pulsed radiofrequency (RF) |
| Group III will be treated with cooled radiofrequency (RF) | Experimental | uses cooled radiofrequency energy to deactivate pain-causing nerves Receives: Device: cooled radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale after intervention
Decrement (clinical improvement) in visual analogue scale (VAS) immediately after intervention. The participant's knee discomfort was measured using a VAS. Participants were asked to score their level of pain on a 100-mm horizontal line, ranging from 0 to 100.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mamdouh Abdelaziz Farag, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664371
- Sponsor's protocol ID
- 36265PR83/5/26
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Results will be published by the investigators in academic journal.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoneurolysis Versus Radiofrequency in Knee Osteoarthritis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07664371
- Acronym / sponsor ID
- 36265PR83/5/26
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Jun 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.
The project will evaluate the effectiveness of Cryoneurolysis versus radiofrequency procedures in adult patients who are resistant to traditional treatment for knee pain. They are a drug-free pain management procedure.
Detailed description
The main approach to OA management is pain control. Cryoneurolysis versus radiofrequency in decreasing knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I will be treated with Cryoneurolysis | Experimental | Device: CryoneurolysisCryoneurolysis freezes nerves |
| Group II will be treated with pulsed radiofrequency (RF) | Experimental | Device: pulsed radiofrequency (RF)radiofrequency (RF) uses electric pulses |
| Group III will be treated with cooled radiofrequency (RF) | Experimental | Device: cooled radiofrequencyuses cooled radiofrequency energy to deactivate pain-causing nerves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with a clinical diagnosis of refractory knee OA who suffered from refractory knee pain (patients who had failed conservative medical and physical therapy for 6 months .
Key exclusion criteria (8 listed)
- Patients with OA show improvement in pain after conservative medical and physical therapy.
- Patients evaluated by an orthopedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
- Patients with allergies to local anesthetics.
- patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
- Patients with knee tumors.
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 |
|---|---|---|
| CryoneurolysisCryoneurolysis freezes nerves | Device | Group I will be treated with Cryoneurolysis |
| pulsed radiofrequency (RF)radiofrequency (RF) uses electric pulses | Device | Group II will be treated with pulsed radiofrequency (RF) |
| cooled radiofrequencyuses cooled radiofrequency energy to deactivate pain-causing nerves | Device | Group III will be treated with cooled radiofrequency (RF) |
Primary outcome
Change in visual analogue scale after intervention
Time frame: immediately after intervention
Decrement (clinical improvement) in visual analogue scale (VAS) immediately after intervention. The participant's knee discomfort was measured using a VAS. Participants were asked to score their level of pain on a 100-mm horizontal line, ranging from 0 to 100.
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Results will be published by the investigators in academic journal.
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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 Cryoneurolysis, pulsed radiofrequency (RF) and cooled radiofrequency in people with Knee Osteoarthritis, run by Tanta 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 1 inclusion and 8 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 11 Aug 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 Aliaa Mamdouh Abdelaziz Farag, MD (+201069468486, aliaa.mamdouh@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analogue scale after intervention (time frame: immediately after intervention). 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 11 Aug 2026.