RecruitingNot ApplicableNCT06514755

Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain

Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain Management: A Randomized Controlled Trial

Sponsor

Zagazig University

Enrollment

60 participants

Start Date

Sep 29, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Knee Pain Osteoarthritis

Summary

The goal of this clinical trial is to evaluate whether performing genicular nerve ablation (GNA) before geniculate artery embolization (GAE) improves pain relief and knee function in patients with chronic knee pain. The main questions it aims to answer are: * Does performing GNA prior to GAE enhance pain relief, as measured by the Visual Analog Scale (VAS), at 3 months post-procedure? * Does the sequential approach improve knee function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)? Study investigators will compare two groups to see if the sequential approach (GNA followed by GAE) provides better outcomes compared to GAE alone. Participants will: * Undergo either sequential GNA followed by GAE or GAE alone * Have their knee pain and function assessed at baseline, 1 month, 3 months, and 6 months post-procedure * Complete a structured patient satisfaction questionnaire (PSQ) at 3 months post-procedure * Be monitored for procedure-related adverse events up to 6 months post-procedure,

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Adults aged 18 to 80 years.
Diagnosed with chronic knee pain refractory to conservative treatment.
Able to provide informed consent.
Agree to follow the study procedures and attend follow-up visits.

Exclusion Criteria4

Contraindications to GNA or GAE procedures (e.g., allergy to local anesthetics, active infection at the procedure site).
Recent knee surgery within the last six months.
Severe comorbid conditions that may interfere with the study outcomes (e.g., rheumatoid arthritis, other severe autoimmune diseases).
Current participation in another clinical trial that could interfere with the outcomes of this study.

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Interventions

PROCEDUREGNA followed by GAE

Participants in the experimental arm will undergo genicular nerve ablation (GNA), a minimally invasive procedure targeting the genicular nerves to interrupt pain transmission. One month after undergoing GNA, participants will receive geniculate artery embolization (GAE), which targets the geniculate arteries to reduce inflammation and pain.

PROCEDUREGAE alone

Participants in the active comparator arm will receive geniculate artery embolization (GAE) alone, a minimally invasive procedure targeting the geniculate arteries to reduce inflammation and pain, without prior genicular nerve ablation (GNA).