Knee Osteoarthritis \(OA\)NCT06594003
Motor Sparing Techniques, Genicular Nerve Radiofrequency Ablation Has Emerged As a Viable Alternative to Conservative Therapy and Total Knee Arthroplasty
A study testing Radiofrequency in people with Knee Osteoarthritis \(OA\), run by Assiut University at 1 site in Egypt.
Trial summary
There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis \(OA\)
- What is being tested?
- Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Nov 2026
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 50-70 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Patients with 3rd and 4th degree of KOA pain who undergo knee articular branch denervation via RF ablation.
Who cannot join
- Deformities in knee.
- Charcot joint (stiff Joint)
- Acute knee injury
- Previous ipsilateral total knee arthroplasty or radiofrequency denervation.
- Instability of knee Joint.
- Knee effusion \& Baker's cyst . . Inability to assume a recumbent or semirecumbent position.
Trial locations and contacts
1 site in 1 country.
Amal Ibrahim Amal Ibrahim Mubarak, assistant lecturer contact
About this study
Official title: Comparative Study Between Eight Versus Three Genicular Nerves Radiofrequency Ablation for Knee Denervation in Advanced Knee Osteoarthritis Using Ultrasound
There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support
Read the detailed description
Knee pain is a common issue in adults, with a steadily increasing prevalence (1). There are many causes of knee pain, such as meniscal and tendon injuries, posttraumatic syndrome, and postsurgical pain; osteoarthritis is the leading cause (2).
Knee osteoarthrosis (KOA) is a very common joint disease, with a prevalence ranging from 4.2% to 15.5% and gradually increasing with age (3). It is associated with diverse causes including age, obesity, metabolic bone diseases, and acute or chronic joint injuries. Pain and disabilities are the major consequences of KOA, with 25% of patients suffering from severe arthralgia. KOA is believed to be a result of the failure of chondrocytes to maintain homeostasis between the synthesis and degradation of the extracellular matrix and from subchondral bone developing osteoarthrosis (4, 5).
Although traditional treatment modalities, including analgesics, physical therapy, and intra-articular steroid (IAS) injections, have long been employed to manage symptoms, the growing need for more effective and minimally invasive interventions has prompted the exploration of novel approaches (6).
Among these newer treatments, motor sparing techniques, genicular nerve radiofrequency ablation has emerged as a viable alternative to conservative therapy and total knee arthroplasty (7).
Genicular nerve ablation is a known procedure to help these cases as they transfer the pain signal of the knee. It is usually reserved for patients with symptomatic knee osteoarthritis who have had failure of conservative treatment and have had failure of or are poor candidates for surgery (8).
However, there is a high failure rate among the patients undergoing the procedure as regarding the efficacy or the duration of pain relief and various methods have been used to increase the rate of success and the duration of the pain relief such as using alcohol in the ablation, cooled radiofrequency or increase the lesions on the nerves (9, 10).
There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support (13).
- Conditions
- Knee Osteoarthritis \(OA\)
- Being tested
- Radiofrequency
- Keywords
- knee, osteoarthritis, radiofrequency, genicular nerves
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyProcedure or surgery
There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves . Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support
| Study group | Role | What they receive |
|---|---|---|
| three genicular nerves raiofrequency ablation | Active comparator | Not described Receives: Procedure: Radiofrequency |
| eight genicular nerves radiofrequency ablation | Active comparator | Not described Receives: Procedure: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
vas score
will be assessed at 0, 1, and 4 weeks. on the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain).
Measured: 4 weeks
Secondary outcomes (4)
Total WOMAC score.
will be assessed at 0, 1, and 4 weeks
Measured: 4 weeks
seven-point Likert scale
seven-point Likert scale (one = worst ever, two = much worse, three = worse, four = not improved but not worse, five = improved, six = much improved, and seven = best ever).
Measured: 4 weeks
analgesic request
Measured: 4 weeks
adverse effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis \(OA\)Studies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Ibrahim Mubarak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594003
- Sponsor's protocol ID
- genicular nerves ablation
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kwon HJ, Kim CS, Kim DH, Shin JW, Choi D, Choi SS. Effectiveness of the Cooled Radiofrequency Ablation of Genicular Nerves in Patients with Chronic Knee Pain Due to Osteoarthritis: A Double-Blind, Randomized, Controlled Study. Medicina (Kaunas). 2024 May 24;60(6):857. doi: 10.3390/medicina60060857.
PubMed 38929474Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.
PubMed 31257831Wehling P, Evans C, Wehling J, Maixner W. Effectiveness of intra-articular therapies in osteoarthritis: a literature review. Ther Adv Musculoskelet Dis. 2017 Aug;9(8):183-196. doi: 10.1177/1759720X17712695. Epub 2017 Jun 20.
PubMed 28835778Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
PubMed 31333900Karm MH, Kwon HJ, Kim CS, Kim DH, Shin JW, Choi SS. Cooled radiofrequency ablation of genicular nerves for knee osteoarthritis. Korean J Pain. 2024 Jan 1;37(1):13-25. doi: 10.3344/kjp.23344.
PubMed 38155108Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.
PubMed 37745043Primorac D, Molnar V, Matisic V, Hudetz D, Jelec Z, Rod E, Cukelj F, Vidovic D, Vrdoljak T, Dobricic B, Anticevic D, Smolic M, Miskulin M, Cacic D, Boric I. Comprehensive Review of Knee Osteoarthritis Pharmacological Treatment and the Latest Professional Societies' Guidelines. Pharmaceuticals (Basel). 2021 Mar 2;14(3):205. doi: 10.3390/ph14030205.
PubMed 33801304Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.
PubMed 32722615Ng TK, Lam KHS, Allam AE. Motor-Sparing Neural Ablation with Modified Techniques for Knee Pain: Case Series on Knee Osteoarthritis and Updated Review of the Underlying Anatomy and Available Techniques. Biomed Res Int. 2022 May 31;2022:2685898. doi: 10.1155/2022/2685898. eCollection 2022.
PubMed 35686229Leite CBG, Merkely G, Charles JF, Lattermann C. From Inflammation to Resolution: Specialized Pro-resolving Mediators in Posttraumatic Osteoarthritis. Curr Osteoporos Rep. 2023 Dec;21(6):758-770. doi: 10.1007/s11914-023-00817-3. Epub 2023 Aug 24.
PubMed 376158561. Байбусунова А, Нысанбай Г, Шварц Д, Жакеева М. Diagnosis and treatment of knee osteoarthritis: Modern aspects. J Orthop Trauma. 2024;48(12):21-9.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Eight Versus Three Genicular Nerves Radiofrequency Ablation for Knee Denervation in Advanced Knee Osteoarthritis Using Ultrasound
- ClinicalTrials.gov ID
- NCT06594003
- Acronym / sponsor ID
- genicular nerves ablation
- Conditions
- Knee Osteoarthritis \(OA\)
- Keywords
- knee, osteoarthritis, radiofrequency, genicular nerves
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support
Detailed description
Knee pain is a common issue in adults, with a steadily increasing prevalence (1). There are many causes of knee pain, such as meniscal and tendon injuries, posttraumatic syndrome, and postsurgical pain; osteoarthritis is the leading cause (2).
Knee osteoarthrosis (KOA) is a very common joint disease, with a prevalence ranging from 4.2% to 15.5% and gradually increasing with age (3). It is associated with diverse causes including age, obesity, metabolic bone diseases, and acute or chronic joint injuries. Pain and disabilities are the major consequences of KOA, with 25% of patients suffering from severe arthralgia. KOA is believed to be a result of the failure of chondrocytes to maintain homeostasis between the synthesis and degradation of the extracellular matrix and from subchondral bone developing osteoarthrosis (4, 5).
Although traditional treatment modalities, including analgesics, physical therapy, and intra-articular steroid (IAS) injections, have long been employed to manage symptoms, the growing need for more effective and minimally invasive interventions has prompted the exploration of novel approaches (6).
Among these newer treatments, motor sparing techniques, genicular nerve radiofrequency ablation has emerged as a viable alternative to conservative therapy and total knee arthroplasty (7).
Genicular nerve ablation is a known procedure to help these cases as they transfer the pain signal of the knee. It is usually reserved for patients with symptomatic knee osteoarthritis who have had failure of conservative treatment and have had failure of or are poor candidates for surgery (8).
However, there is a high failure rate among the patients undergoing the procedure as regarding the efficacy or the duration of pain relief and various methods have been used to increase the rate of success and the duration of the pain relief such as using alcohol in the ablation, cooled radiofrequency or increase the lesions on the nerves (9, 10).
There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support (13).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| three genicular nerves raiofrequency ablation | Active comparator | Procedure: Radiofrequency |
| eight genicular nerves radiofrequency ablation | Active comparator | Procedure: Radiofrequency |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 50-70 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Patients with 3rd and 4th degree of KOA pain who undergo knee articular branch denervation via RF ablation.
Key exclusion criteria (6 listed)
- Deformities in knee.
- Charcot joint (stiff Joint)
- Acute knee injury
- Previous ipsilateral total knee arthroplasty or radiofrequency denervation.
- Instability of knee Joint.
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 |
|---|---|---|
| RadiofrequencyThere has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves . Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support | Procedure or surgery | eight genicular nerves radiofrequency ablation, three genicular nerves raiofrequency ablation |
Primary outcome
vas score
Time frame: 4 weeks
will be assessed at 0, 1, and 4 weeks. on the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain).
4 secondary outcomes
Total WOMAC score.
Time frame: 4 weeks
seven-point Likert scale
Time frame: 4 weeks
analgesic request
Time frame: 4 weeks
adverse effects
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 38929474Kwon HJ, Kim CS, Kim DH, Shin JW, Choi D, Choi SS. Effectiveness of the Cooled Radiofrequency Ablation of Genicular Nerves in Patients with Chronic Knee Pain Due to Osteoarthritis: A Double-Blind, Randomized, Controlled Study. Medicina (Kaunas). 2024 May 24;60(6):857. doi: 10.3390/medicina60060857.
- Background: PubMed 31257831Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.
- Background: PubMed 28835778Wehling P, Evans C, Wehling J, Maixner W. Effectiveness of intra-articular therapies in osteoarthritis: a literature review. Ther Adv Musculoskelet Dis. 2017 Aug;9(8):183-196. doi: 10.1177/1759720X17712695. Epub 2017 Jun 20.
- Background: PubMed 31333900Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
- Background: PubMed 38155108Karm MH, Kwon HJ, Kim CS, Kim DH, Shin JW, Choi SS. Cooled radiofrequency ablation of genicular nerves for knee osteoarthritis. Korean J Pain. 2024 Jan 1;37(1):13-25. doi: 10.3344/kjp.23344.
- Background: PubMed 37745043Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.
- Background: PubMed 33801304Primorac D, Molnar V, Matisic V, Hudetz D, Jelec Z, Rod E, Cukelj F, Vidovic D, Vrdoljak T, Dobricic B, Anticevic D, Smolic M, Miskulin M, Cacic D, Boric I. Comprehensive Review of Knee Osteoarthritis Pharmacological Treatment and the Latest Professional Societies' Guidelines. Pharmaceuticals (Basel). 2021 Mar 2;14(3):205. doi: 10.3390/ph14030205.
- Background: PubMed 32722615Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.
- Background: PubMed 35686229Ng TK, Lam KHS, Allam AE. Motor-Sparing Neural Ablation with Modified Techniques for Knee Pain: Case Series on Knee Osteoarthritis and Updated Review of the Underlying Anatomy and Available Techniques. Biomed Res Int. 2022 May 31;2022:2685898. doi: 10.1155/2022/2685898. eCollection 2022.
- Background: PubMed 37615856Leite CBG, Merkely G, Charles JF, Lattermann C. From Inflammation to Resolution: Specialized Pro-resolving Mediators in Posttraumatic Osteoarthritis. Curr Osteoporos Rep. 2023 Dec;21(6):758-770. doi: 10.1007/s11914-023-00817-3. Epub 2023 Aug 24.
- Background1. Байбусунова А, Нысанбай Г, Шварц Д, Жакеева М. Diagnosis and treatment of knee osteoarthritis: Modern aspects. J Orthop Trauma. 2024;48(12):21-9.
- Individual participant dataSharing planned: Undecided
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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.
Amal Ibrahim Amal Ibrahim Mubarak, assistant lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Knee Osteoarthritis \(OA\), 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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Amal Ibrahim Amal Ibrahim Mubarak, assistant lecturer (01067820046 ext. +2, amalibrahim210@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vas score (time frame: 4 weeks). 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 NCT06594003, which also lists 11 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 19 Sep 2024.