An interventional study of Ultrasound guided infiltration and Fluoroscopy guided infiltration in Chronic Low-back Pain and Lumbar Facet Joint Syndrome, sponsored by Centre Hospitalier Universitaire Saint Pierre. Completed at 3 sites in Belgium. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Not applicable, Interventional, and Treatment
In adults with chronic low back pain, the investigators will compare the effectiveness of the medial bundle branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed either by radiographic guidance or by ultrasound approach according to a transverse approach.
The objective of this study will be to evaluate the benefit of these both procedures on pain, on the practice of daily activities and the incidence of adverse events in order to show whether the two modalities are equivalent.
"Lumbar facet syndrome" is a source of spinal distress affecting up to 45% of patients with chronic low back pain due to inflammation, degenerative or arthritic changes, overloading of the posterior or posterior lumbar facet joints.
First-line treatment for the relief of chronic low back pain of zygapophyseal joint origin includes bed rest, oral pain relievers / anti-inflammatory drugs, and physiotherapy. If unsuccessful, intra-articular injections and medial bundle branch block (BBM) provide diagnosis and are an alternative to neurotomy (radiofrequency or cryoneurolysis).
The BBM targets the medial branches of the posterior twigs, that is, it blocks the nociceptors and the muscles of the dermatome undertaken by targeting the medial branches of the dorsal vertebral branch supplying a facet above and below the vertebrae which ensure sensory innervation of the facet joint. The current standard technique is radiography requiring three punctures (transverse-axial plane) and the ultrasound technique is also described in this plan and also requires three puncture points. The investigatorswould like to compare this promising new technique to the standard radiographic technique since it would avoid irradiation and is easier to handle.
For this study, the investigatorswill compare the BBM on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed under radiography versus ultrasound according to a transverse approach.
To compare the equivalence of this two modalities the investigators will evaluate :
A screening for anxiety and depressive disorders will be also performed before infiltration by the Hospital Anxiety and depression scale (HADS) comprising 14 items.
91 studies on the registry are indexed under Bundle-Branch Block; 29 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 56 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
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The patient is positioned in the prone position with a block under his stomach. After disinfection of the lumbosacral region with alcoholic chlorhexidine 0.5%, the investigators position the convex probe of the ultrasound machine in the transverse plane. Once the spine has been located, the investigators look for the spinous processes of the lower lumbar vertebrae L4 and L5 with the mark on the cranial side and the side opposite the mark on the side of the sacrum. The latter is visualized as a continuous hyperechoic line. Then, the probe is tilted 90 ° to be in a transverse plane. A 22G needle is introduced in a transverse axis starting from the laterality by inserting it in the direction of the median bone contacts of the lower lumbar vertebrae L3, L4 and L5. An infiltration will be unilaterally performed at three levels (L3-L4, L4-L5 and L5-S1 levels).
Other: Ultrasound guided infiltration
The patient is positioned in the prone position with a block under his stomach. The lumbosacral region is disinfected with alcoholic chlorhexidine 0.5%. The C-shaped arm of a X-ray fluoroscopy is positioned around the patient in an antero-posterior view tilted ¾ in order to free the classic view called "scotty dogs ". The puncture point is determined by the positioning of the needle in so-called "tunnel vision". The needle is thus brought to the bone contact corresponding to the eye of the scotty dog in tunnel vision, an area corresponding to the passage of the lumbar median branch. An infiltration will be unilaterally performed at three levels (L3-L4, L4-L5 and L5-S1 levels).
Other: Fluoroscopy guided infiltration
In the patient in prone position, an infiltration guided by ultrasound will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected.
In the patient in prone position, an infiltration guided by fluoroscopy will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected.
Oswestry Disability Index (ODI) score
Change in Oswestry Disability Index (ODI) score from baseline to 1 month after infiltration. Oswestry Disability Index (ODI) will be calculated before and 1 month after procedure. This index (range 0 to 100) is used by clinicians and researchers to quantify disability for low back pain, with higher score indicating greater disability.
Time frame: 1 month
Oswestry Disability Index (ODI) score
Change in Oswestry Disability Index (ODI) score from baseline to 1 week after infiltration. Oswestry Disability Index (ODI) will be calculated before and 1 week after procedure. This index (range 0 to 100) is used by clinicians and researchers to quantify disability for low back pain, with higher score indicating greater disability.
Time frame: 1 week
Change in Visual Analog Scale (VAS) pain score from baseline to 1 week after infiltration
Pain will be evaluated by Visual Analog Scale (VAS) before and 1 week after infiltration. Visual Analog pain score (scale= 0 no pain; 10= worst pain imaginable)
Time frame: 1 week
Change in Visual Analog Scale (VAS) pain score from baseline to 1 month after infiltration
Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after infiltration. Visual Analog pain score (scale= 0 no pain; 10= worst pain imaginable)
Time frame: 1 month
Change in Duke Activity Status Index (DASI) from baseline to 1 week after infiltration
The Duke Activity Status Index (DASI) (range 0 to 58.2) will be calculated before and 1 week after procedure. This index is an assessment tool used to evaluate the possibility of carrying out daily activities, with higher scores indicating a higher functional capacity.
Time frame: 1 week
Change in Duke Activity Status Index (DASI) from baseline to 1 month after infiltration
The Duke Activity Status Index (DASI) (range 0 to 58.2) will be calculated before and 1 month after procedure. This index is an assessment tool used to evaluate the possibility of carrying out daily activities, with higher scores indicating a higher functional capacity.
Time frame: 1 month
Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)
Time frame: 1 month
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) (range 0 to 21) will be calculated before procedure. (0-7 normal; 8-10 Borderline abnormal; 11-21 Abnormal)
Time frame: Before infiltration
Plan to share: No
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Centre Hospitalier Universitaire Saint Pierre