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

NCT ID: NCT04876859

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2024-11-30

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.

Conditions

Hip Osteoarthritis; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional Radiofrequency 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.

Group Type: ACTIVE_COMPARATOR

CRF of anterior sensitive branches to the hip

Intervention Type: PROCEDURE

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.

Anesthetic plus steroid group

The sham group will be submitted to the same anesthetic block as described in the intervention group, followed by a simulation of CRF use.

Group Type: SHAM_COMPARATOR

Anesthetic block with steroid injection of anterior sensitive branches to the hip

Intervention Type: PROCEDURE

Corticosteroid and anesthetic extra articular injection at the sensitive branches of obturator and femoral nerve, only

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Participants 18 years or older
• Symptomatic unilateral hip osteoarthritis (OA)
• Pain for more than 6 months in the groin, anterior, anterolateral ou lateral region
• OA radiologically classified as Kellgren and Lawrence Tipo II-IV,
• VAS ≥ 4
• Considered non-responder to conservative treatment for the participant for 6 months.
• In case of difficulty in selecting participants with symptomatic unilateral OA, symptomatic bilateral hip OA will be admitted and submitted to the same treatment on both sides, after notification and approval from the Ethic Board of each institution involved.

Exclusion Criteria

• Participants with radiculopathy ipsolateral
• Knee OA ipsolateral,
• Previous hip arthroplasty
• Pain exclusively in the posterior region of the hip
• Infiltration of the hip for less than 3 months
• Neurological disease compromising gait
• Peripheral neuropathy
• Psychiatric disease that compromise collaboration with the protocol
• Implanted pacemaker
• Prothrombin Activity Time (PT/INR) > 3 and
• Litigation process related to the disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Brasilia

OTHER

Sponsor Role: lead

Responsible Party

João Luiz Q. Durigan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João Durigan, PhD

Role: STUDY_DIRECTOR

Universidade de Brasilia

Locations

Hospital das Forças Armadas

Brasília, Federal District, Brazil

Countries

Brazil

Other Identifiers

CAAE: 40347320.1.1001.0025

Identifier Type: -

Identifier Source: org_study_id