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

Not Applicable

Completed

• Conditions: Chronic Low-back Pain; Lumbar Facet Joint Syndrome
• Interventions: Other: Ultrasound guided infiltration; Other: Fluoroscopy guided infiltration

• Registration Number: NCT04658953
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Study Start: 2021-01-06
• Status Verified: 2022-03
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided infiltration	Ultrasound guided infiltration	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).
Fluoroscopy-guided infiltration	Fluoroscopy 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).

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI) score	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI) score	1 week	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.
Change in Visual Analog Scale (VAS) pain score from baseline to 1 week after infiltration	1 week	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)
Change in Duke Activity Status Index (DASI) from baseline to 1 month after infiltration	1 month	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.
Change in Visual Analog Scale (VAS) pain score from baseline to 1 month after infiltration	1 month	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)
Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)	1 month
Change in Duke Activity Status Index (DASI) from baseline to 1 week after infiltration	1 week	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.
Hospital Anxiety and Depression Scale (HADS)	Before infiltration	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)

Trial Locations

Locations (3)

CHU Saint-Pierre; 🇧🇪 Bruxelles, Belgium

Hôpital Erasme; 🇧🇪 Bruxelles, Belgium

Hôpital de Braine l'Alleud Waterloo; 🇧🇪 Braine-l'Alleud, Belgium