Osteoarthritis, KneeNCT05591768
Monopolar Versus Biopolar Radiofrequency in OA Knee Pain
A study testing Monopolar radiofrequency and Bipolar radiofrequency in people with Osteoarthritis, Knee, run by Assiut University at 1 site in Egypt.
Trial summary
This is a prospective randomized controlled trial study will aim to evaluate the the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA). And to compare the complications and time taken to complete the procedures. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Monopolar radiofrequency and Bipolar radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2022to 1 Jun 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) outpatient clinic with osteoarthritis-character chronic knee pain, OA grades II-IV (Kellgren and Lawrence scale).
- Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
- Patients refused surgery. (4) Patients after failed conservative treatment for 3 months and reported more than 50% pain relief after diagnostic genicular nerve block with 2% of 2 mL lidocaine on superior lateral, superior medial and inferior medial genicular nerves.
Who cannot join
- Patients with acute knee pain, previous knee surgery, other connective tissue disorders affecting the knee.
- serious neurologic or psychiatric disorders, those had previously received radiofrequency ablation therapy for similar symptoms.
- contraindications for genicular nerve block or genicular nerve RF (active infection, bleeding disorders, current use of anticoagulants or antiplatelets, allergy against the drugs used during the protocol, pregnancy, cardiac pacemaker.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Efficacy of Monopolar Versus Bipolar Radiofrequency Ablation of the Genicular Nerves in the Treatment of Knee Osteoarthritis Pain.
This is a prospective randomized controlled trial study will aim to evaluate the the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA). And to compare the complications and time taken to complete the procedures.
Read the detailed description
Chronic knee pain due to osteoarthritis (OA) is a debilitating disease. Many therapeutic options have been used to manage this pain . Although there are many pharmacological and surgical treatment options for knee osteoarthritis, these entail a number of concerns. Non-steroidal anti-inflammatory drugs can be used for the initial management of osteoarthritis . Intra-articular corticosteroid injection is another option suggested in the guidelines for the treatment of knee osteoarthritis . Surgical procedures are generally performed in cases unresponsive to the conservative treatment options. Joint replacement is the most commonly performed surgical procedure .Genicular nerve ablation with radiofrequency (RF) has recently become a promising treatment option in the management of osteoarthritis related knee pain. In conventional monopolar radiofrequency ablation (MRFA) technique, the localisation of genicular nerves is done through sensory stimulation at the junction of epicondyle with the shaft of femur bone near periosteum. Added to this, the procedure can be distressing when during localisation of genicular nerves the RF cannula comes in contact with pain-sensitive structures such as the periosteum and ligament insertion sites . Bipolar radiofrequency ablation Two radiofrequency cannula are advanced towards the nerve. The novel idea to use bipolar RFA in this study was to produce a larger lesion, thus may minimize the chance to miss the lesion of genicular nerves. Also Placing two electrodes avoids manipulation required to localise the genicular nerves with inadvertent stimulation of pain-sensitive periosteum . So investigaters need to see experimentally if bipolar radiofrequency ablation (BRFA) near the target nerve area without manipulation for localisation of genicular nerves has the ability to reduce the procedural pain than Monopolar radiofrequency.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Monopolar radiofrequency, Bipolar 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.
Monopolar radiofrequencyProcedure or surgery
In monopolar group : . Inferomedial, superomedial, superolateral GN branches and nerve to vastus intermedius of the patients were identified with fluoroscopy and a 22 Gauge, 10 cm radiofrequency (RF) cannula with a 10 mm active tip was advanced to the targeted nerves under fluoroscopy guidance. The location of the RF cannula was visualized by anteriorposterior and lateral images. Sensory stimulation was applied at 50 Hz to determine the nerve position. Since the sensory stimulation threshold must be < 0.6 V, nerve position was tested with the absence of fasciculation in the relevant area of the lower extremity upon 2.0 V stimulation at 2 Hz.
Bipolar radiofrequencyProcedure or surgery
a similar technique will be used to insert the canula, except that, instead of one cannula two cannulae (approximately 10 mm apart) apart) will be inserted and no manipulation of cannulae was done to stimulate the target nerve as done in MRFA Target areas were similar to monopolar technique Each nerve will be ablated for 2 minutes in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures.
| Study group | Role | What they receive |
|---|---|---|
| MBA group monopolar radiofrequency group. | Experimental | Inferomedial, superomedial, superolateral GN branches and nerve to vastus intermediate of the patients were identified with fluoroscopy, and a 22 Gauge, 10 cm radiofrequency (RF) cannula with a 10 mm active tip was advanced to the targeted nerves under fluoroscopy guidance. The location of the RF cannula was visualized by anteriorposterior and lateral images. Sensory stimulation was applied at 50 Hz to determine the nerve position. Since the sensory stimulation threshold must be < 0.6 V, nerve position was tested with the absence of fasciculation in the relevant area of the lower extremity upon 2.0 V stimulation at 2 Hz. Receives: Procedure: Monopolar radiofrequency |
| BFA group bipolar radiofrequency group | Experimental | similar technique will be used to insert the canula, except that, instead of one cannula two cannulae (approximately 10 mm apart) apart) will be inserted and no manipulation of cannulae was done to stimulate the target nerve as done in MRFA Target areas were similar to monopolar technique Each nerve will be ablated for 2 minutes in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures Receives: Procedure: Bipolar radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and procedural pain
Is to evaluate the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA) by questionnaire participants
Measured: Baseline
Secondary outcomes (1)
Knee pain and function
Evaluation of knee pain and function by oxford knee score (score ranged from 0-48 points
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start14 Nov 2022
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Abo Elkasem, Assiut University
- Investigators
- Hany Ahmed ibrahim, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591768
- Sponsor's protocol ID
- Radiofrequency in OA knee pain
- Status last verified
- Oct 2022
- First submitted
- 18 Aug 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.
PubMed 24373908
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Monopolar Versus Bipolar Radiofrequency Ablation of the Genicular Nerves in the Treatment of Knee Osteoarthritis Pain.
- ClinicalTrials.gov ID
- NCT05591768
- Acronym / sponsor ID
- Radiofrequency in OA knee pain
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Oct 2022 (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 is a prospective randomized controlled trial study will aim to evaluate the the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA). And to compare the complications and time taken to complete the procedures.
Detailed description
Chronic knee pain due to osteoarthritis (OA) is a debilitating disease. Many therapeutic options have been used to manage this pain . Although there are many pharmacological and surgical treatment options for knee osteoarthritis, these entail a number of concerns. Non-steroidal anti-inflammatory drugs can be used for the initial management of osteoarthritis . Intra-articular corticosteroid injection is another option suggested in the guidelines for the treatment of knee osteoarthritis . Surgical procedures are generally performed in cases unresponsive to the conservative treatment options. Joint replacement is the most commonly performed surgical procedure .Genicular nerve ablation with radiofrequency (RF) has recently become a promising treatment option in the management of osteoarthritis related knee pain. In conventional monopolar radiofrequency ablation (MRFA) technique, the localisation of genicular nerves is done through sensory stimulation at the junction of epicondyle with the shaft of femur bone near periosteum. Added to this, the procedure can be distressing when during localisation of genicular nerves the RF cannula comes in contact with pain-sensitive structures such as the periosteum and ligament insertion sites . Bipolar radiofrequency ablation Two radiofrequency cannula are advanced towards the nerve. The novel idea to use bipolar RFA in this study was to produce a larger lesion, thus may minimize the chance to miss the lesion of genicular nerves. Also Placing two electrodes avoids manipulation required to localise the genicular nerves with inadvertent stimulation of pain-sensitive periosteum . So investigaters need to see experimentally if bipolar radiofrequency ablation (BRFA) near the target nerve area without manipulation for localisation of genicular nerves has the ability to reduce the procedural pain than Monopolar radiofrequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBA group monopolar radiofrequency group. | Experimental | Procedure: Monopolar radiofrequencyInferomedial, superomedial, superolateral GN branches and nerve to vastus intermediate of the patients were identified with fluoroscopy, and a 22 Gauge, 10 cm radiofrequency (RF) cannula with a 10 mm active tip was advanced to the targeted nerves under fluoroscopy guidance. The location of the RF cannula was visualized by anteriorposterior and lateral images. Sensory stimulation was applied at 50 Hz to determine the nerve position. Since the sensory stimulation threshold must be < 0.6 V, nerve position was tested with the absence of fasciculation in the relevant area of the lower extremity upon 2.0 V stimulation at 2 Hz. |
| BFA group bipolar radiofrequency group | Experimental | Procedure: Bipolar radiofrequencysimilar technique will be used to insert the canula, except that, instead of one cannula two cannulae (approximately 10 mm apart) apart) will be inserted and no manipulation of cannulae was done to stimulate the target nerve as done in MRFA Target areas were similar to monopolar technique Each nerve will be ablated for 2 minutes in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (1) outpatient clinic with osteoarthritis-character chronic knee pain, OA grades II-IV (Kellgren and Lawrence scale).
Key exclusion criteria (4 listed)
- Patients with acute knee pain, previous knee surgery, other connective tissue disorders affecting the knee.
- serious neurologic or psychiatric disorders, those had previously received radiofrequency ablation therapy for similar symptoms.
- contraindications for genicular nerve block or genicular nerve RF (active infection, bleeding disorders, current use of anticoagulants or antiplatelets, allergy against the drugs used during the protocol, pregnancy, cardiac pacemaker.
- -
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 |
|---|---|---|
| Monopolar radiofrequencyIn monopolar group : . Inferomedial, superomedial, superolateral GN branches and nerve to vastus intermedius of the patients were identified with fluoroscopy and a 22 Gauge, 10 cm radiofrequency (RF) cannula with a 10 mm active tip was advanced to the targeted nerves under fluoroscopy guidance. The location of the RF cannula was visualized by anteriorposterior and lateral images. Sensory stimulation was applied at 50 Hz to determine the nerve position. Since the sensory stimulation threshold must be < 0.6 V, nerve position was tested with the absence of fasciculation in the relevant area of the lower extremity upon 2.0 V stimulation at 2 Hz. | Procedure or surgery | MBA group monopolar radiofrequency group. |
| Bipolar radiofrequencya similar technique will be used to insert the canula, except that, instead of one cannula two cannulae (approximately 10 mm apart) apart) will be inserted and no manipulation of cannulae was done to stimulate the target nerve as done in MRFA Target areas were similar to monopolar technique Each nerve will be ablated for 2 minutes in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures. | Procedure or surgery | BFA group bipolar radiofrequency group |
Primary outcome
Efficacy and procedural pain
Time frame: Baseline
Is to evaluate the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA) by questionnaire participants
1 secondary outcome
Knee pain and function
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 21055873Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
- Results publication: PubMed 24373908Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.
- Individual participant dataSharing planned: No
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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.
Hany Ahmed ibrahim, Professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar radiofrequency and Bipolar radiofrequency in people with Osteoarthritis, Knee, run by Assiut 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and procedural pain (time frame: Baseline). 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 NCT05591768, which also lists 2 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 6 Aug 2026.