Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZagazig University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GNA followed by GAE
Procedure/SurgeryParticipants 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.
GAE alone
Procedure/SurgeryParticipants 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sequential GNA Followed by GAEExperimental treatment 1 intervention
Group B: GAE AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduction in Knee Pain
This outcome measures the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.
Time frame
3 months post-procedureSecondary outcomes
1
Improvement in Knee Function
Assessed by changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, which measure pain, stiffness, and physical function of the knee and hip joints. A lower WOMAC score indicates better joint function.
Time frame
Assessed at 1 month, 3 months, and 6 months post-procedure2
Incidence of Procedure-Related Adverse Events
Monitoring and recording any adverse events related to the genicular nerve ablation procedures
Time frame
From the time of procedure up to 6 months3
Patient Satisfaction with the Procedure
Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure.
Time frame
3 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov