NCT04876859

Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis

Conventional Radiofrequency of Anterior Sensory Branches in Chronic Hip Pain Due to Hip Osteoarthritis: A Randomized Clinical Trial

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Osteoarthritis
• Chronic Pain

Interventions

Type	Name	Description
PROCEDURE	CRF of anterior sensitive branches to the hip	Steroid and anesthetic extra articular injection followed by denervation using CRF at 90 celsius degree during a period 90 minutes at the sensitive branches of obturator and femoral nerve, separately.
PROCEDURE	Anesthetic block with steroid injection of anterior sensitive branches to the hip	Corticosteroid and anesthetic extra articular injection at the sensitive branches of obturator and femoral nerve, only

Timeline

• Start date: 2021-06-08
• Primary completion: 2024-10-31
• Completion: 2024-11-30
• First posted: 2021-05-07
• Last updated: 2023-05-24

Locations

1 site across 1 country: Brazil