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

NCT04658953 | Completed

• 1 other identifier: CE/20-11-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (7)

• Oswestry Disability Index (ODI) score

  1 week

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

  1 week

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

  1 month

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

  1 week

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

  1 month

Study Arms (2)

Ultrasound-guided infiltration

EXPERIMENTAL

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

Fluoroscopy-guided infiltration

EXPERIMENTAL

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

Interventions

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.

Ultrasound-guided infiltration

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.

Fluoroscopy-guided infiltration

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Hôpital de Braine-l'Alleud: collaborator
• Erasme University Hospital: collaborator

Study Sites (3)

Hôpital de Braine l'Alleud Waterloo

Braine-l'Alleud, 1420, Belgium

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (12)

• 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.

  PMID: 28422871 BACKGROUND

• Won HS, Yang M, Kim YD. Facet joint injections for management of low back pain: a clinically focused review. Anesth Pain Med (Seoul). 2020 Jan 31;15(1):8-18. doi: 10.17085/apm.2020.15.1.8.

  PMID: 33329784 BACKGROUND

• 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.

  PMID: 18354721 BACKGROUND

• 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.

  PMID: 31524141 BACKGROUND

• Hurdle MF. Ultrasound-Guided Spinal Procedures for Pain: A Review. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):673-86. doi: 10.1016/j.pmr.2016.04.011.

  PMID: 27468672 BACKGROUND

• Ha DH, Shim DM, Kim TK, Kim YM, Choi SS. Comparison of ultrasonography- and fluoroscopy-guided facet joint block in the lumbar spine. Asian Spine J. 2010 Jun;4(1):15-22. doi: 10.4184/asj.2010.4.1.15. Epub 2010 Apr 26.

  PMID: 20622950 BACKGROUND

• Kastler A, Kogl N, Gruber H, Skalla E, Loizides A. Lumbar medial branch cryoneurolysis under ultrasound guidance: initial report of five cases. Med Ultrason. 2020 Sep 5;22(3):293-298. doi: 10.11152/mu-2529.

  PMID: 32898203 BACKGROUND

• Ye L, Wen C, Liu H. Ultrasound-guided versus low dose computed tomography scanning guidance for lumbar facet joint injections: same accuracy and efficiency. BMC Anesthesiol. 2018 Nov 7;18(1):160. doi: 10.1186/s12871-018-0620-7.

  PMID: 30404599 BACKGROUND

• Kaye AD, Motejunas MW, Bonneval LA, Ehrhardt KP, Latimer DR, Trescot A, Wilson KE, Ibrahim IN, Cornett EM, Urman RD, Candido KD. Ultrasound practice for chronic pain procedures: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):465-486. doi: 10.1016/j.bpa.2019.07.001. Epub 2019 Jul 18.

  PMID: 31791564 BACKGROUND

• Yun DH, Kim HS, Yoo SD, Kim DH, Chon JM, Choi SH, Hwang DG, Jung PK. Efficacy of ultrasonography-guided injections in patients with facet syndrome of the low lumbar spine. Ann Rehabil Med. 2012 Feb;36(1):66-71. doi: 10.5535/arm.2012.36.1.66. Epub 2012 Feb 29.

  PMID: 22506237 BACKGROUND

• Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007 Jan;10(1):229-53.

  PMID: 17256032 BACKGROUND

• Greher M, Kirchmair L, Enna B, Kovacs P, Gustorff B, Kapral S, Moriggl B. Ultrasound-guided lumbar facet nerve block: accuracy of a new technique confirmed by computed tomography. Anesthesiology. 2004 Nov;101(5):1195-200. doi: 10.1097/00000542-200411000-00020.

  PMID: 15505456 BACKGROUND

MeSH Terms

Conditions

Pain; Bronchiolitis Obliterans Syndrome; Low Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Back Pain

Study Officials

• Turgay Tuna, MD,PhD

  Erasme University Hospital

  STUDY DIRECTOR

• Marie-Laure Nisolle, MD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

• Panayota Kapessidou, MD,PhD

  Centre Hospitalier Universitaire Saint Pierre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: January 6, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)