Knee OsteoarthritisNCT05962463
Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
This study is intended to prove the efficacy and safety of ultrasound-guided pulsed radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Canal adductor blockade and Canal adductor pulsed radio-frequency therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 128 participants
- Where
- 1 siteSlovenia
- Study dates
- 9 Oct 2024to Jun 2025
- Phase
- Observational
- 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 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants included in this study were sent by family physicians to our Pain ambulance and all have already been diagnosed with knee osteoarthritis chronic pain. The diagnosis was confirmed by Orthopedist engaged in our study. Anesthesiologist decides if the patient is appropriate for the study.
Who may be able to join
- Diagnose of the Knee osteoarthritis confirmed by orthopedic examination
- K-L grades 3 and 4
- A sufficient level of education to understand study procedures
- Be able to communicate with site personnel
- Age >45 years
Who cannot join
- Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
- Severe neurologic conditions interfere with a knee condition
- Narcotic dependent (opioid intake of more than 3 months and more than 30 mg of daily oral morphine equivalents)
- Coexisting severe hematological disorder or deranged coagulation parameters
- Psychiatric illnesses
- Allergy to any of the drugs used in the study
Show all 9Show fewer
- Infection or malignancy at the site of the block
- Any active systemic infection
- Implanted electronic devices like spinal cord stimulators, cardiac pacemakers or similar
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre
Ljubljana, 1000
Mensur Salihovic, 0038640208892, mensur.salihovic@kclj.si
Boris Rijavec
About this study
Official title: Comparison of the Effectiveness of Pulsed Radiofrequency Therapy and Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis
This study is intended to prove the efficacy and safety of ultrasound-guided pulsed radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.
Read the detailed description
Knee osteoarthritis is a serious epidemiologic problem. Non-surgical methods are shown limited efficacy in relieving chronic knee pain in patients in advanced stages of knee osteoarthritis. The knee prosthesis is a successful treatment for many patients with advanced knee osteoarthritis. Still, there are important numbers of patients, which are not appropriate candidates for such surgery treatment or refused surgery for any reason. For them, any treatment which could relieve pain in their knee would have a good impact on their quality of life. Interventions like adductor canal block(ACB) and pulsed radiofrequency therapy (PRF) have demonstrated good results. In this study, investigators compare the effectiveness of these two methods. Official approval from the ethics committee of the Republic of Slovenia was obtained for this study. After being informed about the research and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with a confirmed diagnosis of knee osteoarthritis that lasted more than 6 months will be included in the study. All participants were randomly divided into two groups. Participants in the first group receive single shot ACB and participants in the second group receive PRF therapy at the same point. Before starting all patients filled the Knee injury and osteoarthritis outcome(KOOS) form and estimated the maximal and minimal intensity of pain in the knee. They repeat self-assessment of pain, in the same manner, using 11 points numeric rating score(NRS) 1 month, 3, and six months after the blockade or PRF therapy. Measurement of maximum voluntary isometric contraction of the quadriceps muscle (MVIC), time up and go test(TUG), and 30s stand-up chair test are performed by a physiotherapist before a block of adductor canal on both legs,1 hour, 1 month, 3 months and 6 months after a block or PRF therapy.The adductor canal blockl is performed by the same trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg of Clonidine mixed in the same syringeAfterof the study participants filled the Knee injury and osteoarthritis outcome(KOOS) form once again.
- Conditions
- Knee Osteoarthritis
- Being tested
- Canal adductor blockade, Canal adductor pulsed radio-frequency therapy
- Keywords
- Adductor canal blockade, Radiofrequency therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canal adductor blockadeProcedure or surgery
The same experienced anesthesiologist has performed all blocks. Always after surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade. After the blockade, all participants were monitored in our ambulance for the next hour.
Canal adductor pulsed radio-frequency therapyProcedure or surgery
The same experienced anesthesiologist has performed all PRF therapy After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. We've previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42ºC. After the treatment, all participants were monitored in our ambulance for the next hour.
| Study group | Role | What they receive |
|---|---|---|
| Canal adductor blockade | After surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade with 14 ml 0,25% levobupivacaine and 100 mcg clonidine mixed in the same syringe. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the 10 cm echogenic ultrasound needle. After the blockade, all participants were monitored in our ambulance for the next hour. Receives: Procedure: Canal adductor blockade | |
| Pulsed radiofrequency therapy | After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42. Before starting the PRF therapy all participants have gotten 2 ml 0,25% levobupivacaine through the needle for preventing discomfort during the procedure. After the treatment, all participants were monitored in our ambulance for the next hour. Receives: Procedure: Canal adductor pulsed radio-frequency therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS 0-11) ;Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain.
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
KOOS
The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block [ Time Frame: Baseline and 1 month following adductor canal block ] KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
Secondary outcomes (5)
Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
Maximum voluntary isometric contraction of quadriceps muscle (MVIC) measured by handheld dynamometer ] This method is used to check impact of block on contraction of quadriceps muscle.
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
Timed up to go test (TUG)
Time that patient need to stand up from a standard height armchair,walk 3 meters,go back to the chair and takes a seat.Used to assess a patients balance,risk of falling and global mobility
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
Satisfaction of patient
We determine whether the patient is satisfied with the result of treatment by asking the following question: "what is the least amount of success that the treatment would have to achieve by the end of the study and/or treatment for the patient to conclude that the treatment was worth it and the patient is satisfied?" The patient is asked to describe the minimum goal to be satisfied with the treatment in her own words, such as: "50% reduction in pain, to go to the store without assistance, to use only one cane, to not wake up with pain, to perform regular housekeeping duties at home with minimal breaks, to walk a certain distance, or to play tennis". At the end of the study the patient indicates whether that goal was achieved with a "yes" or "no" answer.
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
Range of knee motion (ROM)
Passive knee joint ROM of extension and flexion was measured in the control and blocked leg in the supine position using a goniometer.
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
30 seconds stand up chair test (30 s SCT)
In the 30 s CST, number of times the participant rises from a chair in 30 s is counted.
Measured: Baseline ,1 hour,1 month, 3 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start9 Oct 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mensur Salihovic, University Medical Centre Ljubljana
- Investigators
- Mensur Salihovic, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962463
- Sponsor's protocol ID
- 0120-464/2022/6
- Status last verified
- Dec 2024
- First submitted
- 2 Jun 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared with all other researchers.
Publications
Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
PubMed 20418016Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
PubMed 21463469Salihovic M, Rijavec B, Muratagic A, Blagus R, Puh U. Effectiveness of Ultrasound-Guided Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis: A Prospective Longitudinal Observational Study. Biomed Res Int. 2022 Jan 22;2022:5270662. doi: 10.1155/2022/5270662. eCollection 2022.
PubMed 35103237Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.
PubMed 27015545Akbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.
PubMed 21558611Carpenedo R, Al-Wardat M, Vizzolo L, Germani G, Chine E, Ridolfo S, Dauri M, Natoli S. Ultrasound-guided pulsed radiofrequency of the saphenous nerve for knee osteoarthritis pain: a pilot randomized trial. Pain Manag. 2022 Mar;12(2):181-193. doi: 10.2217/pmt-2021-0035. Epub 2021 Aug 25.
PubMed 34431329Zhang H, Wang B, He J, Du Z. Efficacy and safety of radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2021 Apr;49(4):3000605211006647. doi: 10.1177/03000605211006647.
PubMed 33887985Uematsu H, Osako S, Hakata S, Kabata D, Shintani A, Kawazoe D, Mizuno K, Fujino Y, Matsuda Y. A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain. Pain Physician. 2021 Sep;24(6):E761-E769.
PubMed 34554694Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.
PubMed 28339430Choi 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 21055873
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Pulsed Radiofrequency Therapy and Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05962463
- Acronym / sponsor ID
- 0120-464/2022/6
- Conditions
- Knee Osteoarthritis
- Keywords
- Adductor canal blockade, Radiofrequency therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Jul 2023 (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 is intended to prove the efficacy and safety of ultrasound-guided pulsed radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.
Detailed description
Knee osteoarthritis is a serious epidemiologic problem. Non-surgical methods are shown limited efficacy in relieving chronic knee pain in patients in advanced stages of knee osteoarthritis. The knee prosthesis is a successful treatment for many patients with advanced knee osteoarthritis. Still, there are important numbers of patients, which are not appropriate candidates for such surgery treatment or refused surgery for any reason. For them, any treatment which could relieve pain in their knee would have a good impact on their quality of life. Interventions like adductor canal block(ACB) and pulsed radiofrequency therapy (PRF) have demonstrated good results. In this study, investigators compare the effectiveness of these two methods. Official approval from the ethics committee of the Republic of Slovenia was obtained for this study. After being informed about the research and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with a confirmed diagnosis of knee osteoarthritis that lasted more than 6 months will be included in the study. All participants were randomly divided into two groups. Participants in the first group receive single shot ACB and participants in the second group receive PRF therapy at the same point. Before starting all patients filled the Knee injury and osteoarthritis outcome(KOOS) form and estimated the maximal and minimal intensity of pain in the knee. They repeat self-assessment of pain, in the same manner, using 11 points numeric rating score(NRS) 1 month, 3, and six months after the blockade or PRF therapy. Measurement of maximum voluntary isometric contraction of the quadriceps muscle (MVIC), time up and go test(TUG), and 30s stand-up chair test are performed by a physiotherapist before a block of adductor canal on both legs,1 hour, 1 month, 3 months and 6 months after a block or PRF therapy.The adductor canal blockl is performed by the same trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg of Clonidine mixed in the same syringeAfterof the study participants filled the Knee injury and osteoarthritis outcome(KOOS) form once again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canal adductor blockade | – | Procedure: Canal adductor blockadeAfter surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade with 14 ml 0,25% levobupivacaine and 100 mcg clonidine mixed in the same syringe. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the 10 cm echogenic ultrasound needle. After the blockade, all participants were monitored in our ambulance for the next hour. |
| Pulsed radiofrequency therapy | – | Procedure: Canal adductor pulsed radio-frequency therapyAfter surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42. Before starting the PRF therapy all participants have gotten 2 ml 0,25% levobupivacaine through the needle for preventing discomfort during the procedure. After the treatment, all participants were monitored in our ambulance for the next hour. |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants included in this study were sent by family physicians to our Pain ambulance and all have already been diagnosed with knee osteoarthritis chronic pain. The diagnosis was confirmed by Orthopedist engaged in our study. Anesthesiologist decides if the patient is appropriate for the study.
Key inclusion criteria (5 listed)
- Diagnose of the Knee osteoarthritis confirmed by orthopedic examination
- K-L grades 3 and 4
- A sufficient level of education to understand study procedures
- Be able to communicate with site personnel
- Age >45 years
Key exclusion criteria (9 listed)
- Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
- Severe neurologic conditions interfere with a knee condition
- Narcotic dependent (opioid intake of more than 3 months and more than 30 mg of daily oral morphine equivalents)
- Coexisting severe hematological disorder or deranged coagulation parameters
- Psychiatric illnesses
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 |
|---|---|---|
| Canal adductor blockadeThe same experienced anesthesiologist has performed all blocks. Always after surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade. After the blockade, all participants were monitored in our ambulance for the next hour. | Procedure or surgery | Canal adductor blockade |
| Canal adductor pulsed radio-frequency therapyThe same experienced anesthesiologist has performed all PRF therapy After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. We've previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42ºC. After the treatment, all participants were monitored in our ambulance for the next hour. | Procedure or surgery | Pulsed radiofrequency therapy |
Primary outcome
Pain intensity
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS 0-11) ;Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain.
KOOS
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block [ Time Frame: Baseline and 1 month following adductor canal block ] KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)
5 secondary outcomes
Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
Timed up to go test (TUG)
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
Satisfaction of patient
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
Range of knee motion (ROM)
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
30 seconds stand up chair test (30 s SCT)
Time frame: Baseline ,1 hour,1 month, 3 month and 6 months
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 9 Dec 2024.
- Background: PubMed 20418016Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
- Background: PubMed 21463469Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
- Background: PubMed 35103237Salihovic M, Rijavec B, Muratagic A, Blagus R, Puh U. Effectiveness of Ultrasound-Guided Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis: A Prospective Longitudinal Observational Study. Biomed Res Int. 2022 Jan 22;2022:5270662. doi: 10.1155/2022/5270662. eCollection 2022.
- Background: PubMed 27015545Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.
- Background: PubMed 21558611Akbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.
- Background: PubMed 34431329Carpenedo R, Al-Wardat M, Vizzolo L, Germani G, Chine E, Ridolfo S, Dauri M, Natoli S. Ultrasound-guided pulsed radiofrequency of the saphenous nerve for knee osteoarthritis pain: a pilot randomized trial. Pain Manag. 2022 Mar;12(2):181-193. doi: 10.2217/pmt-2021-0035. Epub 2021 Aug 25.
- Background: PubMed 33887985Zhang H, Wang B, He J, Du Z. Efficacy and safety of radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2021 Apr;49(4):3000605211006647. doi: 10.1177/03000605211006647.
- Background: PubMed 34554694Uematsu H, Osako S, Hakata S, Kabata D, Shintani A, Kawazoe D, Mizuno K, Fujino Y, Matsuda Y. A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain. Pain Physician. 2021 Sep;24(6):E761-E769.
- Background: PubMed 28339430Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.
- 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared with all other researchers.
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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.
Mensur Salihovic principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 9 Dec 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 Slovenia. 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 Mensur Salihovic, MD (+38640208892, mensur.salihovic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline ,1 hour,1 month, 3 month and 6 months). The study lists 2 primary outcomes in all. 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 NCT05962463, which also lists 10 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 9 Dec 2024.