Osteoarthritis Knee PainReTaKRANCT06934421
Revised Targets for Knee Radiofrequency Ablation
An observational study of Osteoarthritis Knee Pain, run by Centro Hospitalar Universitario do Algarve at 2 sites in Portugal.
Trial summary
This research team is doing a study to learn more about a new way to treat long-term knee pain caused by joint damage. They are using a treatment called radiofrequency ablation (RFA). This is a procedure where doctors use heat to stop certain nerves from sending pain signals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Knee Pain
- What is being tested?
- Ultrasound-Guided Genicular Nerve Radiofrequency Ablation
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 2 sitesPortugal
- Study dates
- 20 Mar 2025to 30 Jul 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the community referred to the Physical and Rehabilitation Medicine department.
Who may be able to join
- Patients with chronic knee pain related to radiographic knee osteoarthritis, Kellgren-Lawrence (KL) grade III or IV, who are refractory to conservative treatment.
- (Refractoriness to conservative treatment is defined as:
- Persistent pain and functional limitation after undergoing knee-targeted physiotherapy and analgesic medication in accordance with clinical guidelines for osteoarthritis [e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and other drugs as deemed appropriate by the treating physician];
- Persistent pain and functional limitation after intra-articular corticosteroid injections or limited success with such interventions.)
Who cannot join
- Patients with previous knee arthroplasty
- Patients who have undergone prior radiofrequency (RF) ablation
- Significant psycho-emotional disorders
- Addictive behaviors
- Generalized pain
- Nociplastic pain
- Presence of a pacemaker
- Presence of osteosynthesis material in the knee or adjacent anatomical regions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites, 2 recruiting
- Recruiting
Serviço de Medicina Física e de Reabilitação - Hospital de Faro - Unidade Local de Saúde do Algarve
Faro, 8000-386
Manuel Tomás Farinha Caroço, Medical Doctor, 968010683, farinhacaroco@gmail.com
Daniela Teixeira, Medical Doctor, +351 914 511 022, danielaspteixeira@gmail.com
- Not yet recruiting
Serviço de Medicina Física e de Reabilitação - Hospital de São Francisco Xavier - Unidade Local de Saúde de Lisboa Ocidental
Lisbon, 1449-005
Giovanni Leoni, Medical Doctor, +39 328 613 3631, gioleoni95@gmail.com
Jorge Barbosa, Medical Doctor, +351 914 729 415, jbarbosa@chlo.min-saude.pt
About this study
Official title: Segurança e eficácia de Nova Abordagem Ecoguiada de ablação Por radiofrequência Dos Nervos Geniculados
This research team is doing a study to learn more about a new way to treat long-term knee pain caused by joint damage. They are using a treatment called radiofrequency ablation (RFA). This is a procedure where doctors use heat to stop certain nerves from sending pain signals.
In this study, doctors will use ultrasound to guide a small needle to nerves around the knee, called genicular nerves. Then, they will apply heat to those nerves using radiofrequency energy to help reduce pain.
Read more
The team created this new method based on recent studies of knee anatomy. They want to find out if this method can safely reduce pain and help people with knee joint damage move better. The study includes people who have moderate to severe knee damage and still have pain after trying medicine, physical therapy, or joint injections.
Each person in the study will have the treatment once. The research team will follow each person for two years. During this time, people in the study will answer simple questions about their knee pain and how it affects their daily life. The researchers will collect this information before the treatment and several times after it. One week after the procedure, the team will call each person to ask how they are feeling and check for any side effects.
Possible benefits of the study include less knee pain and easier movement. Possible risks include pain during the procedure, bruising, swelling, or short-term worsening of pain. Rare risks include nerve problems, weakness, bone damage, or allergic reaction.
The study is free for participants, and there is no payment. Taking part is voluntary. Anyone can stop being in the study at any time without affecting their medical care. The research team will keep all personal information private and secure.
Read the detailed description
This study applies a modified ultrasound-guided radiofrequency ablation (RFA) protocol for targeting the genicular nerves, informed by recent anatomical research. Conventional genicular nerve RFA techniques commonly rely on fluoroscopic or ultrasound guidance based on standard anatomical landmarks. However, cadaveric studies-such as those by Fonkoue et al. (2021)-have shown that these conventional approaches frequently miss the intended nerves, particularly the superomedial and superolateral branches, leading to inconsistent or suboptimal outcomes.
To address these limitations, this protocol incorporates revised probe positioning and alternative bony landmarks aligned with verified nerve pathways. The updated targeting strategy is designed to improve the precision and reproducibility of genicular nerve localization using high-resolution musculoskeletal ultrasound.
The procedure begins with ultrasound identification of the target genicular nerves. Once confirmed, a local anesthetic (2% lidocaine, 20-40 mg per site) is infiltrated to minimize discomfort. Thermal lesioning is then performed using standard 20G RF cannulas at 85°C for 90 seconds. Sensory stimulation (0.2-0.5 V) is used to verify appropriate referral patterns, and motor stimulation (2.0 V) is applied to rule out motor involvement before lesioning. If motor responses are elicited, repositioning or procedure cancellation is considered.
This anatomically informed technique aims to enhance procedural accuracy and consistency. By integrating cadaver-based nerve mapping with real-time ultrasound imaging, the approach has the potential to improve treatment effectiveness while maintaining a strong safety profile. The study will contribute clinical data supporting the feasibility and utility of this refined targeting method in managing knee pain related to joint degeneration.
- Conditions
- Osteoarthritis Knee Pain
- Being tested
- Ultrasound-Guided Genicular Nerve Radiofrequency Ablation
- Keywords
- Genicular nerve, Knee pain, Chronic pain, Knee osteoarthritis, Radiofrequency ablation, Ultrasound guidance, Interventional pain management, Joint degeneration, Nerve ablation, Image-guided procedures, Non-surgical treatment, Musculoskeletal intervention, Pain reduction, Functional improvement
- Medical subject headings
- Chronic Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Genicular Nerve Radiofrequency AblationDevice
Also called Thermal Radiofrequency Ablation of Genicular Nerves, Monopolar Radiofrequency Ablation of Knee Nerves, Image-Guided Genicular Nerve Ablation, Ultrasound-Guided RFA of Knee
This intervention involves a single-session ultrasound-guided thermal radiofrequency ablation of the superomedial, superolateral, and inferomedial genicular nerves in patients with moderate to severe knee osteoarthritis. Target points follow anatomical references described by Fonkoue et al. and validated in cadaveric studies, differing from classical approaches. Under ultrasound guidance, monopolar RF cannulas are placed, with sensory and motor stimulation confirming accurate positioning. Local anesthesia (2% lidocaine) is applied. Lesions are performed at 85°C for 90 seconds per site. The radiofrequency generator used is CE-marked for pain procedures. The study evaluates a novel targeting protocol, not the safety or effectiveness of the device itself. No fluoroscopy is used. The procedure is performed once. Participants are followed for two years to assess outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo | Participants with knee osteoarthrosis (Kellgran-Lawrence III or IV) will receive a single-session ultrasound-guided radiofrequency ablation of the genicular nerves. The procedure targets three specific nerve branches around the knee joint: the superomedial, superolateral, and inferomedial genicular nerves. The targeted positions are based on anatomical reference points described by Fonkoue et al. (2021) and validated in cadaveric studies, aiming to improve the accuracy of nerve localization. Under ultrasound guidance, the clinician will insert a radiofrequency needle at each target site. After confirming correct positioning through sensory and motor stimulation, thermal ablation will be performed at 85ºC for 90 seconds per site. Local anesthesia will be administered before each ablation to ensure patient comfort. This procedure aims to reduce knee pain and improve function in patients with moderate to severe knee joint degeneration who have not responded to conservative treatments. Receives: Device: Ultrasound-Guided Genicular Nerve Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Pain Intensity (Numeric Pain Rating Scale - NPRS)
Change in patient-reported knee pain at rest and during movement, measured using an 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain).
Measured: Baseline to 3 months post-procedure
Secondary outcomes (4)
Change in Physical Function (WOMAC Functional Subscale)
Change in physical function as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Physical Function Subscale. The WOMAC is a validated, self-reported questionnaire assessing functional limitations due to knee osteoarthritis.
This subscale includes 17 items, each scored on a Likert scale from 0 to 4. The total score ranges from 0 to 68, with higher scores indicating worse physical function.
Measured: Baseline to 3 months, 6 months, 1 year, and 2 years post-procedure
Sustained Pain Reduction (Numeric Pain Rating Scale)
Change in pain intensity over time as measured by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain". Patients will report their average knee pain intensity over the past 24 hours. Higher scores indicate worse pain. This outcome assesses the duration and consistency of the analgesic effect following the radiofrequency ablation procedure.
Measured: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years post-procedure
Incidence of Adverse Events
Number and type of adverse events related to the intervention, including local site pain, edema, bruising, motor weakness, neuritis, or other complications.
Measured: From procedure day to 2-year follow-up
Responder Rate (≥50% Pain Reduction)
Proportion of participants achieving ≥50% reduction in NPRS at 3 months post-procedure compared to baseline.
Measured: Baseline to 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start20 Mar 2025
- Primary completion14 Jul 2028 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Knee PainStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitario do Algarve
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Tomás Farinha Caroço, Centro Hospitalar Universitario do Algarve
- Investigators
- Manuel Tomás Farinha Caroço, Medical Doctor, Principal investigator, Unidade Local de Saude do Algarve / Centro Hospitalar Universitario Algarve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934421
- Sponsor's protocol ID
- 025/2025
- Acronym
- ReTaKRA
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications will be shared. This includes pain scores, functional outcomes (WOMAC), adverse event data, and baseline clinical and demographic variables such as age, sex, body mass index (BMI), radiographic knee imaging (image and Kellgren-Lawrence grade), painful knee quadrant, presence of depressive symptoms, and use of opioids, antidepressants, or anxiolytics. A data dictionary will be provided to support interpretation of the dataset.
Publications
Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.
PubMed 32245841Pardal, Margarida Alexandra Rodrigues. Adaptação cultural para português europeu do Western Ontario and McMaster Universities Arthritis Index (WOMAC). Master's Thesis 2023;
De Cassai A, Dost B, Tulgar S. Enhancing the clarity and reproducibility of regional anesthesia techniques: a call for video integration in scientific publications. Reg Anesth Pain Med. 2025 Oct 6;50(10):842-843. doi: 10.1136/rapm-2024-105871. No abstract available.
PubMed 39043621Tran J, Peng P, Agur A. Evaluation of nerve capture using classical landmarks for genicular nerve radiofrequency ablation: 3D cadaveric study. Reg Anesth Pain Med. 2020 Nov;45(11):898-906. doi: 10.1136/rapm-2020-101894. Epub 2020 Sep 14.
PubMed 32928998Tran J, Peng PWH, Chan VWS, Agur AMR. Overview of Innervation of Knee Joint. Phys Med Rehabil Clin N Am. 2021 Nov;32(4):767-778. doi: 10.1016/j.pmr.2021.05.011. Epub 2021 Jul 14.
PubMed 34593142Fonkoue L, Stoenoiu MS, Behets CW, Steyaert A, Kouassi JK, Detrembleur C, Cornu O. Validation of a new protocol for ultrasound-guided genicular nerve radiofrequency ablation with accurate anatomical targets: cadaveric study. Reg Anesth Pain Med. 2021 Mar;46(3):210-216. doi: 10.1136/rapm-2020-101936. Epub 2020 Dec 3.
PubMed 33273065Fonkoue L, Behets C, Kouassi JK, Coyette M, Detrembleur C, Thienpont E, Cornu O. Distribution of sensory nerves supplying the knee joint capsule and implications for genicular blockade and radiofrequency ablation: an anatomical study. Surg Radiol Anat. 2019 Dec;41(12):1461-1471. doi: 10.1007/s00276-019-02291-y. Epub 2019 Jul 23.
PubMed 31338537
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segurança e eficácia de Nova Abordagem Ecoguiada de ablação Por radiofrequência Dos Nervos Geniculados
- ClinicalTrials.gov ID
- NCT06934421
- Acronym / sponsor ID
- ReTaKRA / 025/2025
- Conditions
- Osteoarthritis Knee Pain
- Keywords
- Genicular nerve, Knee pain, Chronic pain, Knee osteoarthritis, Radiofrequency ablation, Ultrasound guidance, Interventional pain management, Joint degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitario do AlgarveUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 14 Jul 2028 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 18 Apr 2025 (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 research team is doing a study to learn more about a new way to treat long-term knee pain caused by joint damage. They are using a treatment called radiofrequency ablation (RFA). This is a procedure where doctors use heat to stop certain nerves from sending pain signals.
In this study, doctors will use ultrasound to guide a small needle to nerves around the knee, called genicular nerves. Then, they will apply heat to those nerves using radiofrequency energy to help reduce pain.
The team created this new method based on recent studies of knee anatomy. They want to find out if this method can safely reduce pain and help people with knee joint damage move better. The study includes people who have moderate to severe knee damage and still have pain after trying medicine, physical therapy, or joint injections.
Each person in the study will have the treatment once. The research team will follow each person for two years. During this time, people in the study will answer simple questions about their knee pain and how it affects their daily life. The researchers will collect this information before the treatment and several times after it. One week after the procedure, the team will call each person to ask how they are feeling and check for any side effects.
Possible benefits of the study include less knee pain and easier movement. Possible risks include pain during the procedure, bruising, swelling, or short-term worsening of pain. Rare risks include nerve problems, weakness, bone damage, or allergic reaction.
The study is free for participants, and there is no payment. Taking part is voluntary. Anyone can stop being in the study at any time without affecting their medical care. The research team will keep all personal information private and secure.
Detailed description
This study applies a modified ultrasound-guided radiofrequency ablation (RFA) protocol for targeting the genicular nerves, informed by recent anatomical research. Conventional genicular nerve RFA techniques commonly rely on fluoroscopic or ultrasound guidance based on standard anatomical landmarks. However, cadaveric studies-such as those by Fonkoue et al. (2021)-have shown that these conventional approaches frequently miss the intended nerves, particularly the superomedial and superolateral branches, leading to inconsistent or suboptimal outcomes.
To address these limitations, this protocol incorporates revised probe positioning and alternative bony landmarks aligned with verified nerve pathways. The updated targeting strategy is designed to improve the precision and reproducibility of genicular nerve localization using high-resolution musculoskeletal ultrasound.
The procedure begins with ultrasound identification of the target genicular nerves. Once confirmed, a local anesthetic (2% lidocaine, 20-40 mg per site) is infiltrated to minimize discomfort. Thermal lesioning is then performed using standard 20G RF cannulas at 85°C for 90 seconds. Sensory stimulation (0.2-0.5 V) is used to verify appropriate referral patterns, and motor stimulation (2.0 V) is applied to rule out motor involvement before lesioning. If motor responses are elicited, repositioning or procedure cancellation is considered.
This anatomically informed technique aims to enhance procedural accuracy and consistency. By integrating cadaver-based nerve mapping with real-time ultrasound imaging, the approach has the potential to improve treatment effectiveness while maintaining a strong safety profile. The study will contribute clinical data supporting the feasibility and utility of this refined targeting method in managing knee pain related to joint degeneration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo | – | Device: Ultrasound-Guided Genicular Nerve Radiofrequency AblationParticipants with knee osteoarthrosis (Kellgran-Lawrence III or IV) will receive a single-session ultrasound-guided radiofrequency ablation of the genicular nerves. The procedure targets three specific nerve branches around the knee joint: the superomedial, superolateral, and inferomedial genicular nerves. The targeted positions are based on anatomical reference points described by Fonkoue et al. (2021) and validated in cadaveric studies, aiming to improve the accuracy of nerve localization. Under ultrasound guidance, the clinician will insert a radiofrequency needle at each target site. After confirming correct positioning through sensory and motor stimulation, thermal ablation will be performed at 85ºC for 90 seconds per site. Local anesthesia will be administered before each ablation to ensure patient comfort. This procedure aims to reduce knee pain and improve function in patients with moderate to severe knee joint degeneration who have not responded to conservative treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the community referred to the Physical and Rehabilitation Medicine department.
Key inclusion criteria (4 listed)
- Patients with chronic knee pain related to radiographic knee osteoarthritis, Kellgren-Lawrence (KL) grade III or IV, who are refractory to conservative treatment.
- Persistent pain and functional limitation after undergoing knee-targeted physiotherapy and analgesic medication in accordance with clinical guidelines for osteoarthritis [e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and other drugs as deemed appropriate by the treating physician];
- Persistent pain and functional limitation after intra-articular corticosteroid injections or limited success with such interventions.)
Key exclusion criteria (8 listed)
- Patients with previous knee arthroplasty
- Patients who have undergone prior radiofrequency (RF) ablation
- Significant psycho-emotional disorders
- Addictive behaviors
- Generalized pain
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 |
|---|---|---|
| Ultrasound-Guided Genicular Nerve Radiofrequency AblationAlso: Thermal Radiofrequency Ablation of Genicular Nerves, Monopolar Radiofrequency Ablation of Knee Nerves, Image-Guided Genicular Nerve Ablation, Ultrasound-Guided RFA of KneeThis intervention involves a single-session ultrasound-guided thermal radiofrequency ablation of the superomedial, superolateral, and inferomedial genicular nerves in patients with moderate to severe knee osteoarthritis. Target points follow anatomical references described by Fonkoue et al. and validated in cadaveric studies, differing from classical approaches. Under ultrasound guidance, monopolar RF cannulas are placed, with sensory and motor stimulation confirming accurate positioning. Local anesthesia (2% lidocaine) is applied. Lesions are performed at 85°C for 90 seconds per site. The radiofrequency generator used is CE-marked for pain procedures. The study evaluates a novel targeting protocol, not the safety or effectiveness of the device itself. No fluoroscopy is used. The procedure is performed once. Participants are followed for two years to assess outcomes. | Device | Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo |
Primary outcome
Change in Knee Pain Intensity (Numeric Pain Rating Scale - NPRS)
Time frame: Baseline to 3 months post-procedure
Change in patient-reported knee pain at rest and during movement, measured using an 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain).
4 secondary outcomes
Change in Physical Function (WOMAC Functional Subscale)
Time frame: Baseline to 3 months, 6 months, 1 year, and 2 years post-procedure
Sustained Pain Reduction (Numeric Pain Rating Scale)
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years post-procedure
Incidence of Adverse Events
Time frame: From procedure day to 2-year follow-up
Responder Rate (≥50% Pain Reduction)
Time frame: Baseline to 3 months post-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 24 Apr 2025.
- Background: PubMed 32245841Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.
- BackgroundPardal, Margarida Alexandra Rodrigues. Adaptação cultural para português europeu do Western Ontario and McMaster Universities Arthritis Index (WOMAC). Master's Thesis 2023;
- Background: PubMed 39043621De Cassai A, Dost B, Tulgar S. Enhancing the clarity and reproducibility of regional anesthesia techniques: a call for video integration in scientific publications. Reg Anesth Pain Med. 2025 Oct 6;50(10):842-843. doi: 10.1136/rapm-2024-105871. No abstract available.
- Background: PubMed 32928998Tran J, Peng P, Agur A. Evaluation of nerve capture using classical landmarks for genicular nerve radiofrequency ablation: 3D cadaveric study. Reg Anesth Pain Med. 2020 Nov;45(11):898-906. doi: 10.1136/rapm-2020-101894. Epub 2020 Sep 14.
- Background: PubMed 34593142Tran J, Peng PWH, Chan VWS, Agur AMR. Overview of Innervation of Knee Joint. Phys Med Rehabil Clin N Am. 2021 Nov;32(4):767-778. doi: 10.1016/j.pmr.2021.05.011. Epub 2021 Jul 14.
- Background: PubMed 33273065Fonkoue L, Stoenoiu MS, Behets CW, Steyaert A, Kouassi JK, Detrembleur C, Cornu O. Validation of a new protocol for ultrasound-guided genicular nerve radiofrequency ablation with accurate anatomical targets: cadaveric study. Reg Anesth Pain Med. 2021 Mar;46(3):210-216. doi: 10.1136/rapm-2020-101936. Epub 2020 Dec 3.
- Background: PubMed 31338537Fonkoue L, Behets C, Kouassi JK, Coyette M, Detrembleur C, Thienpont E, Cornu O. Distribution of sensory nerves supplying the knee joint capsule and implications for genicular blockade and radiofrequency ablation: an anatomical study. Surg Radiol Anat. 2019 Dec;41(12):1461-1471. doi: 10.1007/s00276-019-02291-y. Epub 2019 Jul 23.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in publications will be shared. This includes pain scores, functional outcomes (WOMAC), adverse event data, and baseline clinical and demographic variables such as age, sex, body mass index (BMI), radiographic knee imaging (image and Kellgren-Lawrence grade), painful knee quadrant, presence of depressive symptoms, and use of opioids, antidepressants, or anxiolytics. A data dictionary will be provided to support interpretation of the dataset.
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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.
Manuel Tomás Farinha Caroço, Medical Doctor principal investigator
Unidade Local de Saude do Algarve / Centro Hospitalar Universitario Algarve
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Knee Pain, run by Centro Hospitalar Universitario do Algarve at 2 sites in Portugal.
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 8 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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 Manuel Tomás Farinha Caroço, Medical Doctor (+351968010683, farinhacaroco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain Intensity (Numeric Pain Rating Scale - NPRS) (time frame: Baseline to 3 months post-procedure). 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 NCT06934421, which also lists 7 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 24 Apr 2025.