Actively Recruiting
Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain Management: A Randomized Controlled Trial
Led by Zagazig University · Updated on 2024-10-01
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on patients with chronic knee pain, often related to osteoarthritis, aiming to find out if doing genicular nerve ablation (GNA) before geniculate artery embolization (GAE) improves pain relief and knee function. Researchers want to see if this sequential approach offers better pain reduction and functional improvement compared to GAE alone. The study is a randomized controlled trial designed to compare these two treatment methods and assess safety and patient satisfaction. Participants will be randomly assigned to one of two groups: one group receives GNA targeting the genicular nerves followed by GAE a month later, while the other group receives only GAE. Both procedures are minimally invasive and focus on reducing knee pain by interrupting nerve signals and decreasing inflammation through artery embolization. The study standardizes procedures to maintain consistency. Participants will be evaluated at baseline and then at 1 month, 3 months, and 6 months after treatment. Pain levels will be measured using the Visual Analog Scale (VAS), and knee function will be assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Patient satisfaction questionnaires will be collected at 3 months. Safety monitoring for any procedure-related adverse events will continue up to 6 months. These assessments help researchers understand treatment effects and safety over time.
CONDITIONS
Brief Title
Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with chronic knee pain not responding to conservative treatment
- Able to provide informed consent
- Agree to follow study procedures and attend follow-up visits
You will not qualify if you...
- Contraindications to GNA or GAE procedures, such as allergy to local anesthetics or active infection at the procedure site
- Recent knee surgery within the last six months
- Severe comorbid conditions interfering with study outcomes, like rheumatoid arthritis or other severe autoimmune diseases
- Current participation in another clinical trial that could interfere with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month between GNA and GAE for the sequential group; GAE alone performed once for the comparator group.
Participants undergo either genicular nerve ablation (GNA) followed by geniculate artery embolization (GAE) one month later, or geniculate artery embolization alone, to manage chronic knee pain.
1 to 2 visits depending on treatment assignment
Duration - 6 months post-procedure
Participants are monitored post-procedure with clinical assessments, pain evaluations, functional tests, and documentation of any adverse events.
Visits at 1 week, 1 month, 3 months, and 6 months post-procedure
Trial Site Locations
Total: 1 location
1
Zagazig University, Faculty of Medicine
Zagazig, Egypt, 44519
Actively Recruiting
Research Team
A
Ahmed A Bessar, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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