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

NCT05930236 | Unknown

• 1 other identifier: P2023/034
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Lumbar Facet Joint Syndrome

Keywords

Pain; fluoroscopy; Ultrasound; Injection Site Infiltration; Chronic; facet infiltration

Outcome Measures

Primary Outcomes (1)

• Correct needle placement rate

  Check the correct placement of the needle placed by caudal-cranial approach by X-ray to show if the placement is correct (at the same time)

  0 min

Secondary Outcomes (2)

• change in visual analog scale (VAS) pain score

  30 min

• Incidence of Adverse event

  30 min

Study Arms (1)

ultrasound guided infiltration verified by fluoroscopy

EXPERIMENTAL

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.

Diagnostic Test: Lumbar medial branch block; Drug: Lidocain; Drug: Methylprednisolone; Drug: Omnipaque

Interventions

Lumbar medial branch block 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.

Also known as: LMBB

ultrasound guided infiltration verified by fluoroscopy

Lidocain DRUG

Linisol infiltration with depomedrol and omnipaque

Also known as: linisol

ultrasound guided infiltration verified by fluoroscopy

Methylprednisolone DRUG

infiltration with linisol and omnipaque

Also known as: solumedrol

ultrasound guided infiltration verified by fluoroscopy

Omnipaque DRUG

infiltration with linisol and methylprednisolone

ultrasound guided infiltration verified by fluoroscopy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Pain; Bronchiolitis Obliterans Syndrome

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Iohexol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Marie-Laure Nisolle, MD

CONTACT

+32.2.555.56,19; marie-laure.nisolle@hubruxelles.be

Turgay Tuna, MD, PhD

CONTACT

+32.2.555.31.11; turgay.tuna@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nisolle Marie-Laure, MD

Model Details: the medial branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) will be performed under ultrasound by "caudal-cranial" approach, followed by an X-ray check to verify the positioning of the needle.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 5, 2023
• Study Start: April 21, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)