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

NCT06221709 | Recruiting DMC

• 1 other identifier: f3356f
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Osteoarthritis; Hip Pain Chronic

Keywords

denervation; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Quality of Life (WOMAC)

  The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.

  Baseline to 24 weeks ± 1 week.

Secondary Outcomes (6)

• Change in Pain Visual Analogue Scale

  Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week

• Pain Medication Intake

  Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.

• Change in Hip muscles Isometric Peak Force

  Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.

• Change in Hip muscles Average Force

  Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.

• Change in Global Satisfaction

  Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

This group will be submitted to an intraarticular infiltration of corticosteroid + anesthetic.

Procedure: Intraarticular Infiltration ( Control group)

CRF group

EXPERIMENTAL

This group will be submitted to radiofrequency for sensitive hip branches from the Femoral and Obturator nerves followed by an intraarticular infiltration of corticosteroid + anesthetic similar to the control group.

Procedure: Conventional Radiofrequency (CRF group)

Interventions

Conventional Radiofrequency (CRF group) PROCEDURE

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.

Also known as: Radioablation

CRF group

Intraarticular Infiltration ( Control group) PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead
• Sarah Network of Rehabilitation Hospitals: collaborator

Study Sites (1)

Rede Sarah Hospitais de Reabilitação

Brasília, Federal District, 70335901, Brazil

RECRUITING

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MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Gilvan F Vaz, MD

CONTACT

5561991527220; gilvanvaz@gmail.com

João M Montecchi, MD

CONTACT

+5511944471992; jmontecchi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will be blinded to which group they will be allocated, as well as data assessors, who will not have contact with participants on the day of the procedure. In order to avoid differentiating the number of perforations needed to perform each procedure, all patients will receive the same bandage (Opsite®) in the anterior region of the hip, with instruction to remove it only the day after the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 24, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 24, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available at the moment of publication of the final paper.
• Access Criteria: Open access.

Locations

BR (1)