Background:
Knee osteoarthritis is a chronic degenerative joint disease affecting millions worldwide,
characterized by progressive cartilage loss, inflammation, and pain. Despite various
treatment options such as intra-articular corticosteroids, viscosupplementation, and PRP
injections, many patients experience inadequate relief or adverse effects. Genicular
nerve ablation has emerged as a promising minimally invasive technique to alleviate
chronic knee pain by interrupting pain transmission from the genicular nerves to the
central nervous system.
Rationale:
The rationale for comparing CT-guided and fluoroscopic-guided genicular nerve ablation
lies in optimizing treatment outcomes while ensuring patient safety and satisfaction.
CT-guided procedures offer unparalleled precision in nerve localization, potentially
enhancing the accuracy of nerve ablation and improving clinical outcomes. However, this
method involves higher radiation exposure compared to fluoroscopic guidance, which
utilizes real-time imaging with lower radiation doses. Understanding which approach
provides superior pain relief, functional improvement, and patient satisfaction is
crucial for optimizing treatment protocols and guiding clinical practice.
Objectives:
Primary Objective:
- Evaluate the efficacy of CT-guided and fluoroscopic-guided genicular nerve ablation
in reducing knee pain, 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 comparative
effectiveness of CT-guided versus fluoroscopic-guided genicular nerve ablation. 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.
Participants:
Inclusion Criteria: Adults aged 45-80 diagnosed with knee osteoarthritis refractory
to conservative treatment, characterized by persistent knee pain despite medication
and physical therapy.
Exclusion Criteria: Patients with contraindications to genicular nerve ablation
procedures (e.g., allergy to local anesthetics, active infection at the procedure
site), or recent knee surgery within the last six months.
Interventions:
CT-guided Genicular Nerve Ablation: Patients will undergo CT-guided genicular nerve
ablation, involving meticulous planning of needle placement under CT imaging to
accurately target the genicular nerves responsible for knee pain. Ablation
parameters will be standardized to ensure consistency across procedures.
Fluoroscopic-guided Genicular Nerve Ablation: Patients assigned to this group will
undergo genicular nerve ablation under fluoroscopic guidance, utilizing real-time
X-ray imaging to guide needle placement and confirm adequate nerve coverage before
ablation.
Outcomes:
Primary Outcome: Reduction in knee pain measured by visual analog scale (VAS) at 3
months post-procedure.
Secondary Outcomes
Improvement in knee function measured by changes in WOMAC scores over the follow-up
period.
Incidence and nature of any procedure-related adverse events
Patient-reported outcomes regarding satisfaction, using the structured PSQ
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 comparative effectiveness, safety,
and patient satisfaction of CT-guided versus fluoroscopic-guided genicular nerve ablation
in the management of knee osteoarthritis. 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.