Chronic Low-back PainBLEPACNCT05930236
Ultrasound-guided LMBB by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method
A study testing Lumbar medial branch block, Lidocain and Methylprednisolone in people with Chronic Low-back Pain and Lumbar Facet Joint Syndrome, run by Erasme University Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Low-back Pain, Lumbar Facet Joint Syndrome
- What is being tested?
- Lumbar medial branch block, Lidocain and Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Apr 2023to Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Erasme
Brussels, 1070
Marie-Laure Nisolle, +3225555619, ml.nisolle@hotmail.com
Djamal Ghoundiwal, MD
About this study
Official title: Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method
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.
Read the 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
- Being tested
- Lumbar medial branch block, Lidocain, Methylprednisolone, Omnipaque
- Keywords
- Pain, fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, facet infiltration
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar medial branch blockDiagnostic test
Also called LMBB
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.
LidocainDrug
Also called linisol
Linisol infiltration with depomedrol and omnipaque
Also called solumedrol
infiltration with linisol and omnipaque
OmnipaqueDrug
infiltration with linisol and methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lumbar medial branch block; Drug: Lidocain; Drug: Methylprednisolone; Drug: Omnipaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 min
Secondary outcomes (2)
change in visual analog scale (VAS) pain score
from baseline to 30 min after infiltration. scale (0 = no pain; 10 = worst pain imaginable)
Measured: 30 min
Incidence of Adverse event
(Hematoma, infection, intrathecal injection, spinal anesthesia)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start21 Apr 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Laure Nisolle, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930236
- Sponsor's protocol ID
- P2023/034
- Acronym
- BLEPAC
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No