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:
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.
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:
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.
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.