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

NCT ID: NCT06514755

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-29
• Study Completion Date: 2025-04-30

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.

Conditions

Chronic Knee Pain; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sequential GNA Followed by GAE

Participants in this group will undergo genicular nerve ablation (GNA), followed by geniculate artery embolization (GAE) one month later. The GNA procedure will target the genicular nerves responsible for knee pain, and the GAE procedure will target the geniculate arteries to reduce inflammation and pain. The sequence is designed to optimize pain relief and functional outcomes.

Group Type: EXPERIMENTAL

GNA followed by GAE

Intervention Type: PROCEDURE

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.

GAE Alone

Participants in this group will receive geniculate artery embolization (GAE) alone, without prior genicular nerve ablation (GNA). The GAE procedure will target the geniculate arteries to reduce inflammation and pain. This arm serves as the control to compare the effectiveness and safety of the sequential GNA followed by GAE intervention.

Group Type: ACTIVE_COMPARATOR

GAE alone

Intervention Type: PROCEDURE

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).

Interventions

GNA 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.

Intervention Type: PROCEDURE

GAE 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Awad Bessar

Assistant Professor of Diagnostic and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A Bessar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Locations

Zagazig University, Faculty of Medicine

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed A Bessar, MD, PhD

Role: CONTACT

Ahmedawadbessar@gmail.com

+201000089595

Other Identifiers

GNA-GAE-KP

Identifier Type: -

Identifier Source: org_study_id