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

Federal University of São Paulo

Status: Not yet enrolling

Conditions: Osteoarthritis Knee; Chronic Pain

Treatments: Drug: Chemical Denervation with Absolute Alcohol; Procedure: Continuous Ablative Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT06858228

85243624.3.0000.5505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups

Continuous Ablative Radiofrequency

Active Comparator group

Description:

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.

Treatment:

Procedure: Continuous Ablative Radiofrequency

Chemical Denervation with Absolute Alcohol

Active Comparator group

Description:

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.

Treatment:

Drug: Chemical Denervation with Absolute Alcohol