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

NCT06858228 | Not Yet Recruiting

• 1 other identifier: 85243624.3.0000.5505
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Knee; Chronic Pain

Keywords

Knee Osteoarthritis; Chronic Pain; Denervation; Radiofrequency Ablation; Chemical Neurolysis; Alcohol Neurolysis; Genicular Nerve Ablation; Minimally Invasive Pain Management; Interventional Pain Treatment; Pain Relief

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Numerical Rating Scale (NRS) for Pain

  6 months

• Short Form-36 Health Survey (SF-36)

  6 months

Study Arms (2)

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.

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.

Drug: Chemical Denervation with Absolute Alcohol

Interventions

Continuous Ablative Radiofrequency 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.

Continuous Ablative Radiofrequency

Chemical Denervation with Absolute Alcohol 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.

Chemical Denervation with Absolute Alcohol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo - Hospital Sao Paulo,

São Paulo, São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Leonardo Ferraro, MD, PHD

CONTACT

+5511999516103; leohcferraro@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will use single-blind masking, where participants will be unaware of which treatment they receive. The physicians performing the procedures will not be blinded due to the nature of the interventions. However, the outcome assessors and data analysts will be blinded to the treatment allocation to minimize bias in pain assessments, functional evaluations, and overall study results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Model Details: Group A - Continuous Ablative Radiofrequency Group B - Chemical Denervation with Absolute Alcohol

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)