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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal University of São Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Ablative Radiofrequency

    Procedure/Surgery

    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.

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: Continuous Ablative RadiofrequencyActive comparator 1 intervention
Group B: Chemical Denervation with Absolute AlcoholActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Numerical Rating Scale (NRS) for Pain

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.

Time frame
6 months
2

Short Form-36 Health Survey (SF-36)

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: