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Completed

NCT Number: NCT04658953

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de Braine l'Alleud Waterloo, Braine-l'Alleud, Belgium

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About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided infiltration

Other

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.

Fluoroscopy guided infiltration

Other

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.

Primary outcomes

  1. Oswestry Disability Index (ODI) score

    Time frame: 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 outcomes

  1. Oswestry Disability Index (ODI) score

    Time frame: 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.

  2. Change in Visual Analog Scale (VAS) pain score from baseline to 1 week after infiltration

    Time frame: 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)

  3. Change in Visual Analog Scale (VAS) pain score from baseline to 1 month after infiltration

    Time frame: 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)

  4. Change in Duke Activity Status Index (DASI) from baseline to 1 week after infiltration

    Time frame: 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.

  5. Change in Duke Activity Status Index (DASI) from baseline to 1 month after infiltration

    Time frame: 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.

  6. Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)

    Time frame: 1 month

  7. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • Erasme University Hospital
  • Hôpital de Braine-l'Alleud

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2020
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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