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

NCT04876859 | Suspended Phase 3

• 1 other identifier: CAAE: 40347320.1.1001.0025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Chronic Pain

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 (8)

• Change in Pain Visual Analogue Scale

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

• Change in Harris Hip Score (HHS)

  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 Time to Reach Peak Force

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

Other Outcomes (1)

• Incidence of Adverse Effects

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

Study Arms (2)

Conventional Radiofrequency Group

ACTIVE COMPARATOR

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.

Procedure: CRF of anterior sensitive branches to the hip

Anesthetic plus steroid group

SHAM COMPARATOR

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

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

Interventions

CRF of anterior sensitive branches to the hip 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.

Conventional Radiofrequency Group

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

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

Anesthetic plus steroid group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Hospital das Forças Armadas

Brasília, Federal District, 70673-900, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• João Durigan, PhD

  Universidade de Brasilia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 7, 2021
• Study Start: June 8, 2021
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

BR (1)