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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06514755
Enrollment
60
Registered
2024-07-23
Start date
2024-09-29
Completion date
2025-04-30
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Knee Pain, Osteoarthritis

Keywords

Genicular Nerve Ablation, Geniculate Artery Embolization, Knee Function, Patient Satisfaction

Brief 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,

Detailed description

Background: Chronic knee pain is a prevalent condition affecting a significant portion of the population, often leading to reduced quality of life and functional impairment. Current treatment options include genicular nerve ablation (GNA) and geniculate artery embolization (GAE). However, the optimal sequence of these interventions remains unclear. Rationale: The rationale for investigating the sequence of genicular nerve ablation (GNA) followed by geniculate artery embolization (GAE) lies in potentially optimizing pain relief and functional outcomes while ensuring patient safety and satisfaction. GNA aims to interrupt pain transmission from the genicular nerves to the central nervous system, while GAE targets the blood supply to the inflamed synovium, reducing inflammation and pain. Understanding whether performing GNA prior to GAE offers superior pain relief, functional improvement, and patient satisfaction compared to GAE alone is crucial for optimizing treatment protocols and guiding clinical practice. Objectives: 1. Primary Objective: \- Evaluate whether performing GNA prior to GAE enhances pain relief, as measured by the Visual Analog Scale (VAS), at 3 months post-procedure. 2. Secondary Objectives: * Evaluate changes in knee function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a validated scoring system specifically designed for osteoarthritis. * Monitor and document any procedure-related adverse events to compare the safety profiles of both techniques. * Evaluate patient satisfaction using the structured Patient Satisfaction Questionnaire (PSQ). Study Design: This study is a randomized controlled trial (RCT) aimed at evaluating the effectiveness of sequential GNA followed by GAE versus GAE alone in managing chronic knee pain. Eligible patients will be randomly allocated to one of the two treatment groups. Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments. Interventions: 1. Sequential Genicular Nerve Ablation (GNA) followed by Geniculate Artery Embolization (GAE): Participants will undergo GNA targeting genicular nerves followed by GAE targeting geniculate arteries. Ablation parameters and embolization procedures will be standardized to ensure consistency across interventions. 2. Geniculate Artery Embolization (GAE) Alone: Participants assigned to this group will receive GAE without prior GNA. The embolization procedure will follow standard protocols to target the geniculate arteries effectively. Outcomes: a) Primary Outcome \- Reduction in Knee Pain; this measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement. Secondary Outcomes: * 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. * Incidence of Procedure-Related Adverse Events; monitoring and recording any adverse events related to the genicular nerve ablation procedures. * 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. Follow-Up: Participants will be closely monitored post-procedure with scheduled follow-up visits at 1 week, 1 month, 3 months, and 6 months. These visits will include clinical assessments, pain evaluations, functional tests, and documentation of any adverse events. Conclusion: This study aims to provide valuable insights into the effectiveness, safety, and patient satisfaction of performing genicular nerve ablation prior to geniculate artery embolization in the management of chronic knee pain. By rigorously evaluating these techniques, the findings will inform clinical decision-making, optimize treatment strategies, and pave the way for future research aimed at enhancing outcomes for patients suffering from chronic knee pain.

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).

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.

Intervention model description

Participants will be randomly assigned to one of two groups: one undergoing sequential genicular nerve ablation (GNA) followed by geniculate artery embolization (GAE), and the other receiving GAE alone.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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 criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Knee Pain3 months post-procedureThis 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.

Secondary

MeasureTime frameDescription
Improvement in Knee FunctionAssessed at 1 month, 3 months, and 6 months post-procedureAssessed 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.
Incidence of Procedure-Related Adverse EventsFrom the time of procedure up to 6 monthsMonitoring and recording any adverse events related to the genicular nerve ablation procedures
Patient Satisfaction with the Procedure3 months post-procedureMeasured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure.

Countries

Egypt

Contacts

Primary ContactAhmed A Bessar, MD, PhD
Ahmedawadbessar@gmail.com+201000089595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026