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

Primary Purpose

Chronic Low-back Pain, Lumbar Facet Joint Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ultrasound guided infiltration
Fluoroscopy guided infiltration
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Pain, Fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, Lumbar facet joint syndrome, Medial branch blocks, Disability, Local anesthetic, Lumbalgia, Lumbar zygapophysial joint, Facet syndrome, Chronic Low-back Pain, Medial branch block

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital de Braine l'Alleud Waterloo
  • CHU Saint-Pierre
  • Hôpital Erasme

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasound-guided infiltration

Fluoroscopy-guided infiltration

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2020
Last Updated
March 21, 2022
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Hôpital de Braine-l'Alleud, Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04658953
Brief Title
Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block
Official Title
Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Hôpital de Braine-l'Alleud, Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Lumbar Facet Joint Syndrome
Keywords
Pain, Fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, Lumbar facet joint syndrome, Medial branch blocks, Disability, Local anesthetic, Lumbalgia, Lumbar zygapophysial joint, Facet syndrome, Chronic Low-back Pain, Medial branch block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided infiltration
Arm Type
Experimental
Arm 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).
Arm Title
Fluoroscopy-guided infiltration
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Ultrasound guided infiltration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fluoroscopy guided infiltration
Intervention Description
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 Outcome Measure Information:
Title
Oswestry Disability Index (ODI) score
Description
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
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI) score
Description
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
Title
Change in Visual Analog Scale (VAS) pain score from baseline to 1 week after infiltration
Description
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
Title
Change in Visual Analog Scale (VAS) pain score from baseline to 1 month after infiltration
Description
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
Title
Change in Duke Activity Status Index (DASI) from baseline to 1 week after infiltration
Description
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
Title
Change in Duke Activity Status Index (DASI) from baseline to 1 month after infiltration
Description
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
Title
Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)
Time Frame
1 month
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgay Tuna, MD,PhD
Organizational Affiliation
Hôpital Erasme
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marie-Laure Nisolle, MD
Organizational Affiliation
Centre Hospitalier Universitaire Saint Pierre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panayota Kapessidou, MD,PhD
Organizational Affiliation
Centre Hospitalier Universitaire Saint Pierre
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital de Braine l'Alleud Waterloo
City
Braine-l'Alleud
ZIP/Postal Code
1420
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28422871
Citation
Han SH, Park KD, Cho KR, Park Y. Ultrasound versus fluoroscopy-guided medial branch block for the treatment of lower lumbar facet joint pain: A retrospective comparative study. Medicine (Baltimore). 2017 Apr;96(16):e6655. doi: 10.1097/MD.0000000000006655.
Results Reference
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33329784
Citation
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PubMed Identifier
18354721
Citation
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.
Results Reference
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Citation
Karkucak M, Batmaz I, Kerimoglu S, Ayar A. Comparison of clinical outcomes of ultrasonography-guided and blind local injections in facet syndrome: A 6-week randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(3):431-436. doi: 10.3233/BMR-181447.
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Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block

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