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NCT Number: NCT06858228

Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo - Hospital Sao Paulo,

São Paulo, 04024002, Brazil

Location contact

Leonardo Ferraro, MD, PHD

CONTACT

[email protected]

+5511999516103

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Numerical Rating Scale (NRS) for Pain

    Time frame: 6 months

    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.

  2. Short Form-36 Health Survey (SF-36)

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Leonardo Ferraro, MD, PHD

CONTACT

[email protected]

+5511999516103

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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