Clinical trial NCT06858228: Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A - Continuous Ablative Radiofrequency Group B - Chemical Denervation with Absolute Alcohol
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
timeFrame: 6 months
Secondary outcomes:
measure: Numerical Rating Scale (NRS) for Pain
timeFrame: 6 months
measure: Short Form-36 Health Survey (SF-36)
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Hospital Sao Paulo,
state: SP
Study officials:
References: