Bipolar Radiofrequency AblationNCT07789340
Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
A study testing Unipolar radiofrequency ablation and Bipolar radiofrequency ablation in people with Bipolar Radiofrequency Ablation and Unipolar Radiofrequency Ablation, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation, Knee Osteoarthritis
- What is being tested?
- Unipolar radiofrequency ablation and Bipolar radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2026to 1 Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years.
- Both genders.
- Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA.
- One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
- Kellgren-Lawrence grade (II-IV).
Who cannot join
- Chronic knee pain induced by infection, inflammation, tumors, and fractures.
- Prior knee surgery.
- Acute knee pain.
- Connective tissue diseases.
- Neurologic or psychiatric disorders.
- Intra-articular knee corticosteroid or hyaluronic acids in the past 3 months.
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- Anticoagulant medication.
- Local infection of the site of intervention.
- Cognitive impairment.
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
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
About this study
Official title: Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain: A Randomized Single-Blinded Trial
This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.
Read the detailed description
Osteoarthritis (OA) is one of the most common underlying causes of chronic knee pain resulting in loss of ability. Chronic knee pain due to OA is a debilitating disease. Many therapeutic options have been used to manage this pain such as physical therapy, non-steroid anti-inflammatory drugs (NSAIDs), tramadol, opioids, intraarticular hyaluronic acid, and steroids.
Radiofrequency ablation (RFA) appears to be effective for treatment of knee pain. It acts by interrupting the pain conduction through production of a thermal lesion to interrupt nociceptive signals.
A diagnostic genicular nerve block with local anesthetic is performed before genicular nerve RFA, and a positive result indicates the need for genicular RFA In conventional monopolar RFA (MRFA) technique, the localization of genicular nerves is one through sensory stimulation at the junction of epicondyle with the shaft of femur bone (near periosteum).
- Conditions
- Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation, Knee Osteoarthritis, Pain
- Being tested
- Unipolar radiofrequency ablation, Bipolar radiofrequency ablation
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar radiofrequency ablationProcedure or surgery
Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.
Bipolar radiofrequency ablationProcedure or surgery
Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.
| Study group | Role | What they receive |
|---|---|---|
| Unipolar RFA (URFA) Group | Experimental | Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula. Receives: Procedure: Unipolar radiofrequency ablation |
| Bipolar RFA (BRFA) Group | Experimental | Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas. Receives: Procedure: Bipolar radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successful responders with a reduction 50% of pain
The proportion of successful responders with a reduction 50% of Visual Analog Scale (VAS) will be recorded.
Measured: 24 weeks after the procedure
Secondary outcomes (2)
Degree of pain
Knee pain will be measured by visual Analog Scale (VAS) (0 - no pain to 10-worst imaginable pain) at baseline, 1, 4, 12 and 24 weeks after the procedure during movement.
Measured: 24 weeks after the procedure
Oxford Knee Score (OKS)
The functional changes in the knee will be assessed by Oxford Knee Score (OKS). It is simple, valid, self-administered, joint-specific 12-item questionnaires ranging from 12 to 60, with 12 referred to the best result.
Measured: 24 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 posted27 Aug 2026
- Study start29 Aug 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Radiofrequency AblationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789340
- Sponsor's protocol ID
- 36265PR110/6/26
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain: A Randomized Single-Blinded Trial
- ClinicalTrials.gov ID
- NCT07789340
- Acronym / sponsor ID
- 36265PR110/6/26
- Conditions
- Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation, Knee Osteoarthritis, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 29 Aug 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Aug 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 efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.
Detailed description
Osteoarthritis (OA) is one of the most common underlying causes of chronic knee pain resulting in loss of ability. Chronic knee pain due to OA is a debilitating disease. Many therapeutic options have been used to manage this pain such as physical therapy, non-steroid anti-inflammatory drugs (NSAIDs), tramadol, opioids, intraarticular hyaluronic acid, and steroids.
Radiofrequency ablation (RFA) appears to be effective for treatment of knee pain. It acts by interrupting the pain conduction through production of a thermal lesion to interrupt nociceptive signals.
A diagnostic genicular nerve block with local anesthetic is performed before genicular nerve RFA, and a positive result indicates the need for genicular RFA In conventional monopolar RFA (MRFA) technique, the localization of genicular nerves is one through sensory stimulation at the junction of epicondyle with the shaft of femur bone (near periosteum).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unipolar RFA (URFA) Group | Experimental | Procedure: Unipolar radiofrequency ablationPatients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula. |
| Bipolar RFA (BRFA) Group | Experimental | Procedure: Bipolar radiofrequency ablationPatients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 50 years.
- Both genders.
- Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA.
- One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
- Kellgren-Lawrence grade (II-IV).
Key exclusion criteria (9 listed)
- Chronic knee pain induced by infection, inflammation, tumors, and fractures.
- Prior knee surgery.
- Acute knee pain.
- Connective tissue diseases.
- Neurologic or psychiatric disorders.
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 |
|---|---|---|
| Unipolar radiofrequency ablationPatients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula. | Procedure or surgery | Unipolar RFA (URFA) Group |
| Bipolar radiofrequency ablationPatients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas. | Procedure or surgery | Bipolar RFA (BRFA) Group |
Primary outcome
Proportion of successful responders with a reduction 50% of pain
Time frame: 24 weeks after the procedure
The proportion of successful responders with a reduction 50% of Visual Analog Scale (VAS) will be recorded.
2 secondary outcomes
Degree of pain
Time frame: 24 weeks after the procedure
Oxford Knee Score (OKS)
Time frame: 24 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 4 Nov 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.
Related trials for Bipolar Radiofrequency Ablation
Recruiting
Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis
Cryoneurolysis, Bipolar Radiofrequency Ablation
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 Unipolar radiofrequency ablation and Bipolar radiofrequency ablation in people with Bipolar Radiofrequency Ablation and Unipolar Radiofrequency Ablation, 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 5 inclusion and 9 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 4 Nov 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 Mohammed S Elsharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of successful responders with a reduction 50% of pain (time frame: 24 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 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.