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Not yet recruiting NCT06858228

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

No phase Interventional Osteoarthritis Knee Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous Ablative Radiofrequency, Chemical Denervation with Absolute Alcohol.
Who it may be relevant to
Registry conditions: Osteoarthritis Knee, Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Procedure 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 ablati
  • Drug 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

Primary outcome measures

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score [Time frame: 6 months]
Secondary outcome measures (2)
  • Numerical Rating Scale (NRS) for Pain [Time frame: 6 months]
  • Short Form-36 Health Survey (SF-36) [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Federal University of Sao Paulo - Hospital Sao Paulo, — São Paulo

Identifiers

NCT: NCT06858228 · 85243624.3.0000.5505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗