Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-27 @ 3:15 PM
Study NCT ID:
NCT05591768
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2022-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monopolar Versus Biopolar Radiofrequency in OA Knee Pain
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
The Clinical Efficacy of Monopolar Versus Bipolar Radiofrequency Ablation of the Genicular Nerves in the Treatment of Knee Osteoarthritis Pain.
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized controlled trial study will aim to evaluate the the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA). And to compare the complications and time taken to complete the procedures.
Detailed Description:
Chronic knee pain due to osteoarthritis (OA) is a debilitating disease. Many therapeutic options have been used to manage this pain . Although there are many pharmacological and surgical treatment options for knee osteoarthritis, these entail a number of concerns. Non-steroidal anti-inflammatory drugs can be used for the initial management of osteoarthritis . Intra-articular corticosteroid injection is another option suggested in the guidelines for the treatment of knee osteoarthritis . Surgical procedures are generally performed in cases unresponsive to the conservative treatment options. Joint replacement is the most commonly performed surgical procedure .Genicular nerve ablation with radiofrequency (RF) has recently become a promising treatment option in the management of osteoarthritis related knee pain. In conventional monopolar radiofrequency ablation (MRFA) technique, the localisation of genicular nerves is done through sensory stimulation at the junction of epicondyle with the shaft of femur bone near periosteum. Added to this, the procedure can be distressing when during localisation of genicular nerves the RF cannula comes in contact with pain-sensitive structures such as the periosteum and ligament insertion sites . Bipolar radiofrequency ablation Two radiofrequency cannula are advanced towards the nerve. The novel idea to use bipolar RFA in this study was to produce a larger lesion, thus may minimize the chance to miss the lesion of genicular nerves. Also Placing two electrodes avoids manipulation required to localise the genicular nerves with inadvertent stimulation of pain-sensitive periosteum . So investigaters need to see experimentally if bipolar radiofrequency ablation (BRFA) near the target nerve area without manipulation for localisation of genicular nerves has the ability to reduce the procedural pain than Monopolar radiofrequency.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: