Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hôpital de Braine-l'Alleud | OTHER |
| Erasme University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
"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 :
A screening for anxiety and depressive disorders will be also performed before infiltration by the Hospital Anxiety and depression scale (HADS) comprising 14 items.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de Braine l'Alleud Waterloo | Braine-l'Alleud | 1420 | Belgium | |||
| CHU Saint-Pierre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28422871 | Background | 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. | |
| 33329784 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia) | 1 month |
| 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 |
| Brussels |
| 1000 |
| Belgium |
| Hôpital Erasme | Brussels | 1070 | Belgium |
| 18354721 | 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. |
| 31524141 | 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. |
| 27468672 | 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. |
| 20622950 | 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. |
| 32898203 | 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. |
| 30404599 | 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. |
| 31791564 | 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. |
| 22506237 | 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. |
| 17256032 | 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. |
| 15505456 | 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D001416 | Back Pain |
Not provided
Not provided