Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNational Cancer Institute, Egypt

About this trial

This study aims to compare the reduction in knee pain between ultrasound-guided cryoneurolysis and bipolar radiofrequency ablation (RFA), as measured by the Numerical Rating Scale (NRS) at predefined follow-up intervals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 40 years

Symptomatic knee osteoarthritis (OA) in bladder cancer patient [based on American College of Radiology (ACR) criteria]

Radiological OA (Kellgren-Lawrence grade III-IV)

Chronic knee pain ≥ 3-6 months

Disqualifiers

Prior genicular nerve ablation

Coagulopathy

Local infection

Severe deformity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided cryoneurolysis

    Procedure/Surgery

    Patients will undergo ultrasound-guided cryoneurolysis

  • Bipolar radiofrequency ablation

    Procedure/Surgery

    Patients will undergo bipolar radiofrequency ablation

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cryoneurolysis groupExperimental treatment 1 intervention
Group B: Radiofrequency ablation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Degree of pain

Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

Time frame
6 months after procedure

Secondary outcomes

1

Knee Injury and Osteoarthritis Outcome Score

Knee Injury and Osteoarthritis Outcome Score (KOOS) will measure * Pain * Symptoms * Activities of daily living * Sports/recreation * Quality of life

Time frame
6 months after procedure
2

Western Ontario and McMaster Universities Osteoarthritis Index

Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index is a widely used, self-administered questionnaire that evaluates pain, stiffness, and physical function in patients with knee and hip osteoarthritis.

Time frame
6 months after procedure
3

Oxford Knee Score

The Oxford Knee Score is a 12-item patient-reported questionnaire used to assess pain and physical function in the knee. Score Interpretation 0 to 19 (Severe): May indicate severe knee problems or advanced arthritis; surgical intervention like a knee replacement may be considered. 20 to 29 (Moderate to Severe): Reflects considerable pain and functional limitations. 30 to 39 (Mild to Moderate): Suggests mild-to-moderate joint issues with some activity limitations. 40 to 48 (Satisfactory): Indicates normal or satisfactory joint function with minimal knee problems.

Time frame
6 months after procedure
4

Patient Global Impression of Change (PGIC)

The traditional Patient Global Impression of Change (PGIC) uses a 7-point scale where patients select the statement that best describes their current state compared to how they felt before treatment: 1. Very much improved (or Much better) 2. Much improved 3. Minimally improved 4. No change (or The same) 5. Minimally worse 6. Much worse 7. Very much worse (or Very much worse)

Time frame
6 months after procedure

Other outcomes

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