Ultrasound-guided LMBB by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method

NCT ID: NCT05930236

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2024-06-30

Brief Summary

The current standard technique is radiography requiring three uni- or bilateral punctures (transverse-axial plane). The ultrasound technique is also described mainly in this plan but a new "caudal-cranial" ultrasound-guided technique was described by Chang et al in 2018 in which the major axis is used to conduct the needle to the desired area. The investigators would like to confirm that this new technique in a single puncture is also possible under ultrasound.

Detailed Description

The convex probe is first positioned in the median longitudinal plane opposite the spinous processes of the lower lumbar vertebrae L4 and L5 with the coordinate system on the cranial side and the side opposite the mark on the sacrum side. The latter is visualized as a hyperechogenic continuous line. The probe is then moved away from the midline, the probe is slightly inclined in an oblique paramedian position looking towards the midline, and gradually slid towards laterality in order to reveal successively, the plane of the laminar interlines of the L3, L4 and L5 vertebrae, then the plane of the facelet spacing of these same vertebrae at the junction of the upper and lower articular processes, finally the plane of their transverse processes

Conditions

Chronic Low-back Pain; Lumbar Facet Joint Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ultrasound guided infiltration verified by fluoroscopy

The 22G needle is introduced along a caudal-cranial axis to infiltrate at each level a volume of 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol (Methylprednisolone) 40mg with 1mL of Omnipaque (contrast product). At each level, contrast medium will be injected at the same time as the linisol-depomedrol mixture so that once the BBM under ultrasound is completed, an X-ray check is performed.

Group Type: EXPERIMENTAL

Lumbar medial branch block

Intervention Type: DIAGNOSTIC_TEST

The lumbar medial branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) will be performed by ultrasound-guidance in a longitudinal plane and the correct placement of the needle will be verified by radiography to show if the two modalities are equivalent.

Lidocain

Intervention Type: DRUG

Linisol infiltration with depomedrol and omnipaque

Methylprednisolone

Intervention Type: DRUG

infiltration with linisol and omnipaque

Omnipaque

Intervention Type: DRUG

infiltration with linisol and methylprednisolone

Interventions

Lumbar medial branch block

The lumbar medial branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) will be performed by ultrasound-guidance in a longitudinal plane and the correct placement of the needle will be verified by radiography to show if the two modalities are equivalent.

Intervention Type: DIAGNOSTIC_TEST

Lidocain

Linisol infiltration with depomedrol and omnipaque

Intervention Type: DRUG

Methylprednisolone

infiltration with linisol and omnipaque

Intervention Type: DRUG

Omnipaque

infiltration with linisol and methylprednisolone

Intervention Type: DRUG

Other Intervention Names

LMBB; linisol; solumedrol

Eligibility Criteria

Inclusion Criteria

• chronic low back pain compatible with facet lumbar syndrome with chronic pain of at least 3 months
• who have not responded to conservative treatment after at least 4 weeks
• patients without signs of dissociated pain, radiculitis, neurological diseases including stroke and Parkinson's disease, spinal instability or deformities such as scoliosis, ankylosing spondylitis, history of lumbar surgery, fracture or lumbar tumor

Exclusion Criteria

• Pregnant or breastfeeding women
• Allergy to injected products (Depomedrol or Linisol)
• Psychiatric disorders hindering understanding of the protocol
• Local or systemic infection
• Coagulation disorder
• Obese with a BMI> 35 kg / m²

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marie-Laure Nisolle

Nisolle Marie-Laure, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital Erasme

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Marie-Laure Nisolle, MD

Role: CONTACT

marie-laure.nisolle@hubruxelles.be

+32.2.555.56,19

Turgay Tuna, MD, PhD

Role: CONTACT

turgay.tuna@hubruxelles.be

+32.2.555.31.11

Facility Contacts

Marie-Laure Nisolle

Role: primary

ml.nisolle@hotmail.com

+3225555619

Other Identifiers

P2023/034

Identifier Type: -

Identifier Source: org_study_id