Chronic Knee OsteoarthritisNCT04112264
Ultrasound-guided Monopolar Versus Bipolar Radiofrequency Ablation for Genicular Nerves in Chronic Knee Osteoarthritis
A study testing Monopolar radiofrequency ablation and Bipolar radiofrequency ablation in people with Chronic Knee Osteoarthritis, run by Mansoura University at 1 site in Egypt.
Trial summary
Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation. This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Knee Osteoarthritis
- What is being tested?
- Monopolar 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
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2020to 1 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).
- Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
- Patients refused surgery.
Who cannot join
- Patient refusal.
- Prior knee surgery.
- Acute knee pain.
- Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- Connective tissue diseases that affected the knee.
- Anticoagulant medication use.
- Local skin infection and sepsis at the site of intervention
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, DK, 050
Sherif A Mousa, MD, 00201001637298, S_abdomousa@yahoo.com
Ola T Abd El-Dayem, MD, 00201202811110, Olataha2007@yahoo.com
About this study
Official title: Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis
Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation.
This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.
Read the detailed description
The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis.
Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance
A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation
- Conditions
- Chronic Knee Osteoarthritis
- Being tested
- Monopolar radiofrequency ablation, Bipolar radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar radiofrequency ablationProcedure or surgery
a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
Bipolar radiofrequency ablationProcedure or surgery
Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
| Study group | Role | What they receive |
|---|---|---|
| Monopolar radiofrequency ablation | Experimental | Patients will receive ultrasound-guided monopolar radiofrequency ablation Receives: Procedure: Monopolar radiofrequency ablation |
| Bipolar radiofrequency ablation | Active comparator | Patients will receive ultrasound-guided 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.
Osteoarthritis pain
The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever
Measured: basal value, at 1, 4, 12, 24 weeks post procedure
Secondary outcomes (8)
Oxford Knee Score
A specific score to assess the functional changes in the knee using Oxford Knee Score (OKS). The scores are 12-item questionnaires ranging from 12-60, with 12 representing the optimal outcome.
Measured: basal value, at 1, 4, 12, 24 weeks post procedure
The procedure time
The procedure time taken by each mode of radiofrequency from the start of advancement of the cannula under US guidance to the end of the procedure.
Measured: from the start of advancement of the cannula to end of procedure.
Patient satisfaction score
Patient satisfaction score with treatment which is scored from 1 to 10. A score of 1-4 was considered "dissatisfied," 5-8 was "satisfied," and 9 or 10 was "very satisfied
Measured: up to 24 weeks post procedure
Changes in doses of rescue analgesics
Measured: up to 24 weeks post procedure
The incidence of numbness
Measured: up to 24 weeks post procedure
The incidence of paresthesia
Measured: up to 24 weeks post procedure
The incidence of motor weakness
Measured: up to 24 weeks post procedure
the proportion of successful responders
the proportion of successful responders with a reduction of at least 50% of median VAS score and no increase from baseline OKS
Measured: up to 24 weeks post 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 2019
- Study start4 Oct 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mansoura 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, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif A Mousa, MD, Study chair, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112264
- Sponsor's protocol ID
- MD.19.03.152
- Status last verified
- Oct 2020
- First submitted
- 25 Sep 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol Statistical analysis plan Informed consent form
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04112264
- Acronym / sponsor ID
- MD.19.03.152
- Conditions
- Chronic Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 2 Oct 2019 (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.
Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation.
This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.
Detailed description
The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis.
Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance
A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monopolar radiofrequency ablation | Experimental | Procedure: Monopolar radiofrequency ablationPatients will receive ultrasound-guided monopolar radiofrequency ablation |
| Bipolar radiofrequency ablation | Active comparator | Procedure: Bipolar radiofrequency ablationPatients will receive ultrasound-guided bipolar radiofrequency ablation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).
- Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
- Patients refused surgery.
Key exclusion criteria (7 listed)
- Patient refusal.
- Prior knee surgery.
- Acute knee pain.
- Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- Connective tissue diseases that affected the knee.
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 radiofrequency ablationa radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator. | Procedure or surgery | Monopolar radiofrequency ablation |
| Bipolar radiofrequency ablationTwo radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator. | Procedure or surgery | Bipolar radiofrequency ablation |
Primary outcome
Osteoarthritis pain
Time frame: basal value, at 1, 4, 12, 24 weeks post procedure
The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever
8 secondary outcomes
Oxford Knee Score
Time frame: basal value, at 1, 4, 12, 24 weeks post procedure
The procedure time
Time frame: from the start of advancement of the cannula to end of procedure.
Patient satisfaction score
Time frame: up to 24 weeks post procedure
Changes in doses of rescue analgesics
Time frame: up to 24 weeks post procedure
The incidence of numbness
Time frame: up to 24 weeks post procedure
The incidence of paresthesia
Time frame: up to 24 weeks post procedure
The incidence of motor weakness
Time frame: up to 24 weeks post procedure
the proportion of successful responders
Time frame: up to 24 weeks post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. study protocol Statistical analysis plan Informed consent form
Related trials for Chronic Knee Osteoarthritis
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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
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Medication vs. Meditation for Chronic Knee Osteoarthritis
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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.
Sherif A Mousa, MD study chair
Professor of Anesthesia and Surgical Intensive Care
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 ablation and Bipolar radiofrequency ablation in people with Chronic Knee Osteoarthritis, run by Mansoura 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 7 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif A Mousa, MD (00201001637298, S_abdomousa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoarthritis pain (time frame: basal value, at 1, 4, 12, 24 weeks post 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 8 Oct 2020.