Osteoarthritis KneeNCT06858228
Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
A study testing Continuous Ablative Radiofrequency and Chemical Denervation with Absolute Alcohol in people with Osteoarthritis Knee and Chronic Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. The study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Knee, Chronic Pain
- What is being tested?
- Continuous Ablative Radiofrequency and Chemical Denervation with Absolute Alcohol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2025to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adults aged ≥ 18 years.
- Knee pain for more than 3 months.
- Clinical and imaging-confirmed diagnosis of knee osteoarthritis, based on X-ray, ultrasound, or magnetic resonance imaging (MRI).
Who cannot join
- History of major joint interventions, such as previous knee surgery or arthroplasty.
- Severe joint effusion.
- Coagulation disorders or other clinical contraindications for the procedure.
- Uncontrolled comorbidities that increase procedural risk.
- Body mass index (BMI) > 35.
- Cognitive impairment that affects the ability to understand and respond to pain assessment instruments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Federal University of Sao Paulo - Hospital Sao Paulo,
São Paulo, São Paulo, 04024002
Leonardo Ferraro, MD, PHD, +5511999516103, leohcferraro@yahoo.com.br
About this study
Official title: Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: a Randomized Clinical Trial of Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
This randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. The study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with absolute alcohol, which involves an injection to reduce pain transmission. Participants will be randomly assigned to one of the treatments, and their pain levels, mobility, and quality of life will be monitored over time to determine which method provides better pain relief.
Read the detailed description
This randomized clinical trial compares continuous ablative radiofrequency and chemical denervation with absolute alcohol for pain relief in patients with knee osteoarthritis refractory to conventional treatments. Participants will be randomly assigned to one of the two procedures, with outcomes assessed based on pain reduction, functional improvement, quality of life, and safety. Follow-ups will be conducted for up to six months to evaluate the durability of pain relief, providing evidence to guide clinical management of chronic knee osteoarthritis pain.
- Conditions
- Osteoarthritis Knee, Chronic Pain
- Being tested
- Continuous Ablative Radiofrequency, Chemical Denervation with Absolute Alcohol
- Keywords
- Knee Osteoarthritis, Chronic Pain, Denervation, Radiofrequency Ablation, Chemical Neurolysis, Alcohol Neurolysis, Genicular Nerve Ablation, Minimally Invasive Pain Management, Interventional Pain Treatment, Pain Relief
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Ablative RadiofrequencyProcedure or surgery
Continuous ablative radiofrequency is a minimally invasive neuroablative procedure that targets the sensory genicular nerves to manage pain in knee osteoarthritis. Under ultrasound guidance, a radiofrequency probe is inserted percutaneously near the target nerves. The procedure delivers continuous thermal energy at 80°C for 120 seconds, creating a controlled lesion that disrupts pain signal transmission. This technique is distinct from pulsed radiofrequency, as it aims for permanent nerve ablation rather than neuromodulation. The expected outcome is prolonged pain relief and improved function in patients with chronic knee osteoarthritis refractory to conservative treatments.
Chemical Denervation with Absolute AlcoholDrug
Chemical denervation with absolute alcohol is a minimally invasive neurolytic procedure targeting the sensory genicular nerves to manage chronic knee osteoarthritis pain. Under ultrasound guidance, a percutaneous injection of absolute alcohol 66% is administered near the targeted nerves. The neurolytic effect of alcohol induces axonal degeneration and Wallerian degeneration, leading to prolonged disruption of pain signal transmission. This intervention differs from radiofrequency ablation as it achieves chemical neurolysis rather than thermal ablation, with potential for a distinct duration of analgesia and varying nerve regeneration patterns. The expected outcome is long-lasting pain relief and improved function in patients with knee osteoarthritis who have not responded to conservative treatments.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Ablative Radiofrequency | Active comparator | Participants in this arm will undergo continuous ablative radiofrequency targeting the sensory genicular nerves responsible for knee pain. The procedure involves the percutaneous insertion of a radiofrequency probe near the targeted nerves under imaging guidance. Controlled thermal energy will be applied to create a lesion, disrupting pain signal transmission. The goal is to provide long-lasting pain relief and improve function in patients with knee osteoarthritis. Receives: Procedure: Continuous Ablative Radiofrequency |
| Chemical Denervation with Absolute Alcohol | Active comparator | Participants in this arm will undergo chemical denervation with absolute alcohol, targeting the sensory genicular nerves responsible for knee pain. The procedure involves the percutaneous injection of absolute alcohol near the selected nerves under imaging guidance. The neurolytic effect of alcohol disrupts pain signal transmission, aiming to provide prolonged pain relief and functional improvement in patients with knee osteoarthritis. Receives: Drug: Chemical Denervation with Absolute Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated on a Likert scale (0-4), with higher scores indicating greater pain, stiffness, and functional impairment. The total WOMAC score will be measured at baseline, 1 month, 3 months, and 6 months post-intervention to evaluate the effectiveness of the treatments in improving knee osteoarthritis symptoms.
Measured: 6 months
Secondary outcomes (2)
Numerical Rating Scale (NRS) for Pain
The Numerical Rating Scale (NRS) is an 11-point scale (0-10) used to assess pain intensity, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Participants will rate their pain at rest and during movement at baseline, 1 month, 3 months, and 6 months post-intervention. The NRS is a widely used and validated tool for quantifying pain perception, allowing for objective comparison of pain relief between continuous ablative radiofrequency and chemical denervation with absolute alcohol.
Measured: 6 months
Short Form-36 Health Survey (SF-36)
The SF-36 (Short Form-36 Health Survey) is a validated questionnaire used to assess health-related quality of life (HRQoL) across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, and mental health. Scores range from 0 to 100, with higher scores indicating better health status and quality of life. The SF-36 will be administered at baseline, 1 month, 3 months, and 6 months post-intervention to evaluate the impact of continuous ablative radiofrequency and chemical denervation with absolute alcohol on the overall well-being of patients with knee
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A - Continuous Ablative Radiofrequency Group B - Chemical Denervation with Absolute Alcohol
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Henrique Cunha Ferraro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858228
- Sponsor's protocol ID
- 85243624.3.0000.5505
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: a Randomized Clinical Trial of Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
- ClinicalTrials.gov ID
- NCT06858228
- Acronym / sponsor ID
- 85243624.3.0000.5505
- Conditions
- Osteoarthritis Knee, Chronic Pain
- Keywords
- Knee Osteoarthritis, Chronic Pain, Denervation, Radiofrequency Ablation, Chemical Neurolysis, Alcohol Neurolysis, Genicular Nerve Ablation, Minimally Invasive Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 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 randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. The study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with absolute alcohol, which involves an injection to reduce pain transmission. Participants will be randomly assigned to one of the treatments, and their pain levels, mobility, and quality of life will be monitored over time to determine which method provides better pain relief.
Detailed description
This randomized clinical trial compares continuous ablative radiofrequency and chemical denervation with absolute alcohol for pain relief in patients with knee osteoarthritis refractory to conventional treatments. Participants will be randomly assigned to one of the two procedures, with outcomes assessed based on pain reduction, functional improvement, quality of life, and safety. Follow-ups will be conducted for up to six months to evaluate the durability of pain relief, providing evidence to guide clinical management of chronic knee osteoarthritis pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A - Continuous Ablative Radiofrequency Group B - Chemical Denervation with Absolute Alcohol
| Arm | Type | Receives |
|---|---|---|
| Continuous Ablative Radiofrequency | Active comparator | Procedure: Continuous Ablative RadiofrequencyParticipants in this arm will undergo continuous ablative radiofrequency targeting the sensory genicular nerves responsible for knee pain. The procedure involves the percutaneous insertion of a radiofrequency probe near the targeted nerves under imaging guidance. Controlled thermal energy will be applied to create a lesion, disrupting pain signal transmission. The goal is to provide long-lasting pain relief and improve function in patients with knee osteoarthritis. |
| Chemical Denervation with Absolute Alcohol | Active comparator | Drug: Chemical Denervation with Absolute AlcoholParticipants in this arm will undergo chemical denervation with absolute alcohol, targeting the sensory genicular nerves responsible for knee pain. The procedure involves the percutaneous injection of absolute alcohol near the selected nerves under imaging guidance. The neurolytic effect of alcohol disrupts pain signal transmission, aiming to provide prolonged pain relief and functional improvement in patients with knee osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥ 18 years.
- Knee pain for more than 3 months.
- Clinical and imaging-confirmed diagnosis of knee osteoarthritis, based on X-ray, ultrasound, or magnetic resonance imaging (MRI).
Key exclusion criteria (6 listed)
- History of major joint interventions, such as previous knee surgery or arthroplasty.
- Severe joint effusion.
- Coagulation disorders or other clinical contraindications for the procedure.
- Uncontrolled comorbidities that increase procedural risk.
- Body mass index (BMI) > 35.
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 |
|---|---|---|
| Continuous Ablative RadiofrequencyContinuous ablative radiofrequency is a minimally invasive neuroablative procedure that targets the sensory genicular nerves to manage pain in knee osteoarthritis. Under ultrasound guidance, a radiofrequency probe is inserted percutaneously near the target nerves. The procedure delivers continuous thermal energy at 80°C for 120 seconds, creating a controlled lesion that disrupts pain signal transmission. This technique is distinct from pulsed radiofrequency, as it aims for permanent nerve ablation rather than neuromodulation. The expected outcome is prolonged pain relief and improved function in patients with chronic knee osteoarthritis refractory to conservative treatments. | Procedure or surgery | Continuous Ablative Radiofrequency |
| Chemical Denervation with Absolute AlcoholChemical denervation with absolute alcohol is a minimally invasive neurolytic procedure targeting the sensory genicular nerves to manage chronic knee osteoarthritis pain. Under ultrasound guidance, a percutaneous injection of absolute alcohol 66% is administered near the targeted nerves. The neurolytic effect of alcohol induces axonal degeneration and Wallerian degeneration, leading to prolonged disruption of pain signal transmission. This intervention differs from radiofrequency ablation as it achieves chemical neurolysis rather than thermal ablation, with potential for a distinct duration of analgesia and varying nerve regeneration patterns. The expected outcome is long-lasting pain relief and improved function in patients with knee osteoarthritis who have not responded to conservative treatments. | Drug | Chemical Denervation with Absolute Alcohol |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: 6 months
a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated on a Likert scale (0-4), with higher scores indicating greater pain, stiffness, and functional impairment. The total WOMAC score will be measured at baseline, 1 month, 3 months, and 6 months post-intervention to evaluate the effectiveness of the treatments in improving knee osteoarthritis symptoms.
2 secondary outcomes
Numerical Rating Scale (NRS) for Pain
Time frame: 6 months
Short Form-36 Health Survey (SF-36)
Time frame: 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 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Ablative Radiofrequency and Chemical Denervation with Absolute Alcohol in people with Osteoarthritis Knee and Chronic Pain, run by Federal University of São Paulo at 1 site in Brazil.
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 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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 Brazil. 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 Leonardo Ferraro, MD, PHD (+5511999516103, leohcferraro@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score (time frame: 6 months). 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 11 Mar 2025.