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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658953
• Other study ID #: CE/20-11-10
• Status: Completed
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Bundle-Branch Block
• Chronic Low-back Pain
• Low Back Pain
• Lumbar Facet Joint Syndrome
• Syndrome

Intervention

Other:
• Ultrasound guided infiltration
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
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.

Locations

Country	Name	City	State
Belgium	Hôpital de Braine l'Alleud Waterloo	Braine-l'Alleud
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	Hôpital Erasme	Bruxelles

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Erasme University Hospital, Hôpital de Braine-l'Alleud

Country where clinical trial is conducted

Belgium, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. Review. — View 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. — View Citation

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. — View Citation

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. Review. — View 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 week
Secondary	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)	1 week
Secondary	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)	1 month
Secondary	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.	1 week
Secondary	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.	1 month
Secondary	Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)		1 month
Secondary	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)	Before infiltration