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Clinical Trials in Brazil / NCT06221709
Recruiting Not applicable

Continuous Radiofrequency in Hip Osteoarthritis Pain: A Randomized Clinical Trial.

NCT06221709 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2024-02-01
Last updated
2024-01-24

Condition(s) studied

Hip OsteoarthritisHip Pain Chronic

Investigational drug(s) / intervention(s)

Conventional Radiofrequency (CRF group)Intraarticular Infiltration ( Control group)

Conventional Radiofrequency (CRF group): Radiofrequency will be performed with a 22-gauge CRF cannula, 10/15 cm long, 10mm curved active tip, at 90º for 90 seconds, introduced in the anteroposterior and lateromedial directions, to reach the teardrop landmark. Denervation of the articular branches of the Obturator Nerve will be performed in 2 cycles, starting lateral to the lateral edge of the obturator foramen, followed by a point approximately 1cm lateral to the first point. Next, the cannula will be repositioned in a more cranial location, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve, performing 3 cycles at the 01, 12, and 11 o'clock positions. All lesions will be preceded by motor stimulation at 2,5V and cycles will be followed by the infusion of 2ml of 1% ropivacaine. After concluding the procedure, hip intraarticular infiltration will be performed as described for the control group.

Intraarticular Infiltration ( Control group): For the control group (IA), an epidural anesthesia needle (22G spinal needle) will be used, positioned anteroposteriorly towards the central portion of the femoral neck, which will be introduced until transfixion of the anterior hip capsule through tactile sensitivity. After checking the correct positioning with the use of fluoroscopy and infusion of 3 ml of 50% diluted iodinated contrast, an infusion of 4 ml of 1% Ropivacaine and 80mg of methylprednisolone 40mg/ml will be done.

Study summary

This will be a prospective, single-center, double-blinded, randomized study designed to compare the efficacy of the intraarticular injection of a corticosteroid and the Conventional Radiofrequency (CRF) of the anterior sensory branches to the hip in controlling pain and improving function related to hip osteoarthritis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Individuals ≥ 18 years of age, with symptomatic unilateral hip osteoarthritis, grades II and III according to the Kellgreen and Lawrance classification, hip pain for more than six months (medial, anterior, anterolateral, and/or lateral region) will be included. Exclusion Criteria: * Individuals with radiculopathy and ipsilateral irradiation, osteonecrosis of the femoral head, previous arthroplasty on the hip to be studied or surgical scar that could lead to changes in the anatomy of the hip, cases of high dislocation of the hip, pain exclusively in the posterior region, symptomatic ipsilateral knee osteoarthritis, intra-articular infiltration of corticosteroids or hyaluronic acid in the hip for less than six months, patients with neurological diseases, peripheral neuropathy or psychiatric diseases, use of a pacemaker or Prothrombin Activity Time (INR) \> 3.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Rede Sarah Hospitais de Reabilitação Brasília Federal District Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06221709 on ClinicalTrials.gov ↗ ← All trials in Brazil