Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514755
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain Management A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None