Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol

NCT ID: NCT06858228

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-12-31

Brief 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 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.

Conditions

Osteoarthritis Knee; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Ablative Radiofrequency

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.

Group Type: ACTIVE_COMPARATOR

Continuous Ablative Radiofrequency

Intervention Type: PROCEDURE

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 Alcohol

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.

Group Type: ACTIVE_COMPARATOR

Chemical Denervation with Absolute Alcohol

Intervention Type: DRUG

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.

Interventions

Continuous Ablative Radiofrequency

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.

Intervention Type: PROCEDURE

Chemical Denervation with Absolute Alcohol

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Henrique Cunha Ferraro

Associate Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Sao Paulo - Hospital Sao Paulo,

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Leonardo Ferraro, MD, PHD

Role: CONTACT

leohcferraro@yahoo.com.br

+5511999516103

Facility Contacts

Leonardo Ferraro, MD, PHD

Role: primary

leohcferraro@yahoo.com.br

+5511999516103

Other Identifiers

85243624.3.0000.5505

Identifier Type: -

Identifier Source: org_study_id