Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-27 @ 7:05 AM
Study NCT ID:
NCT04876859
Status:
SUSPENDED
Last Update Posted:
2023-05-24
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis
Sponsor:
University of Brasilia
Organization:
Study Overview
Official Title:
Conventional Radiofrequency of Anterior Sensory Branches in Chronic Hip Pain Due to Hip Osteoarthritis: A Randomized Clinical Trial
Status:
SUSPENDED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Main researcher changed institutions, making it unfeasible to be completed by the others participants.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.
Detailed Description:
This prospective, double-blinded (participant and outcome assessor) clinical trial was designed to investigate the results of the intervention Continuous Radiofrequency (CRF) in the treatment of participants with chronic hip pain secondary to hip osteoarthritis. Participants will be randomized in a 2-arm, parallel groups. The intervention group will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. The sham group will be submitted to the same anesthetic block, followed by a simulation of CRF use. The surgeon performing the procedures will only be informed of the randomization after completing the anesthetic block on the participants to avoid bias at its accuracy. Participants will be evaluated at four follow-up: before intervention and after 1, 12, and 24 weeks, to access the Western Ontario and McMaster Universities score (WOMAC) as the primary outcome.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: