Clinical trial

Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method

Name
P2023/034
Description
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.
Trial arms
Trial start
2023-04-21
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Treatment
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.
Arms:
ultrasound guided infiltration verified by fluoroscopy
Other names:
LMBB
Lidocain
Linisol infiltration with depomedrol and omnipaque
Arms:
ultrasound guided infiltration verified by fluoroscopy
Other names:
linisol
Methylprednisolone
infiltration with linisol and omnipaque
Arms:
ultrasound guided infiltration verified by fluoroscopy
Other names:
solumedrol
Omnipaque
infiltration with linisol and methylprednisolone
Arms:
ultrasound guided infiltration verified by fluoroscopy
Size
40
Primary endpoint
Correct needle placement rate
0 min
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-07-05

1 organization

3 products

2 indications

Product
Lidocain
Indication
Low Back Pain
Product
Omnipaque