Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block

Centre Hospitalier Universitaire Saint Pierre

Status: Completed

Conditions: Chronic Low-back Pain; Lumbar Facet Joint Syndrome

Treatments: Other: Fluoroscopy guided infiltration; Other: Ultrasound guided infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT04658953

CE/20-11-10

Details and patient eligibility

About

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.

Full description

"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 :

• the benefit of the procedure on pain (via the visual analogue scale (VAS) collected before then at 1 week and at 1 month after the infiltrations)
• the evolution of the possibility of carrying out daily activities (via the Duke's activity status index (DASI) scale, collected at the same intervals as the VAS)
• the limits of daily activities (via the Oswestry Disability Index (ODI), collected at the same time intervals)
• the incidence of adverse events

A screening for anxiety and depressive disorders will be also performed before infiltration by the Hospital Anxiety and depression scale (HADS) comprising 14 items.

Enrollment: 50 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Low-back pain for at least 3 months, without response to a conservative treatment of minimum 4 weeks
• No signs of dissociated pain, radiculitis, neurological diseases (including stroke, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ultrasound-guided infiltration

Experimental group

Description:

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).

Treatment:

Other: Ultrasound guided infiltration

Fluoroscopy-guided infiltration

Experimental group

Description:

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).

Treatment:

Other: Fluoroscopy guided infiltration