Ultrasound-guided Lumbar Periradicular Injection: a Non Irradiating Infiltration Technique

NCT03453775 | Unknown

• 1 other identifier: P2018/047
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

We propose here to evaluate the precision of lumbar periradicular infiltration performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. The effectiveness of the technique will be assessed by measuring different pain and disability scores at four weeks post-infiltration: the Visual analogue pain Scale score, the DN4 score, and the Oswestry disability score (ODI); The decrease in irradiation received will be collected, compared to that of the conventional fluoroscopic technique.

Conditions

Low Back Pain; Sciatica; Disc, Herniated; Foraminal Hernia; Lumbar Foraminal Stenosis; Chronic Low Back Pain; Pain, Chronic; Injection Site Infiltration

Outcome Measures

Primary Outcomes (1)

• Effectiveness of needle placement under ultrasound guidance

  Good position: G. Wrong position: W.

  Before infiltration

Secondary Outcomes (4)

• Irradiation doses

  24h

• Visual analogue scale

  Baseline, 2weeks, 4weeks

• Neuropathic pain score: DN4

  Baseline, 2 weeks, 4 weeks

• Oswestry Disability index

  Baseline, 2 weeks, 4 weeks

Study Arms (2)

Ultrasound guided infiltration

ACTIVE COMPARATOR

Ultrasound guided periradicular lumbar infiltration. Prone position. Lumbar spine level located in a median sagittal plane (spinous processes). High resolution curved 5MHz ultrasound probe. Probe is then rotated 90° for a median transverse image. Transverse plane translation towards desired side to have in the same plane: spinous process, vertebral blade, zygapophysial articulation, lateral facet, transverse process. Needle passes skin at 45° angle, directed "in plane" to the foramen. Fluoroscopy then performed to check needle's correct position. Poorly positioned needles will be replaced to obtain an intra-foraminal/epidural periradicular diffusion of the contrast medium. Once position is confirmed, Depomedrol 40mg + lidocaine 2% (1ml) is injected.

Device: Ultrasound guided periradicular lumbar infiltration

Fluoroscopy guided infiltration

ACTIVE COMPARATOR

Fluoroscopy guided periradicular lumbar infiltration. Prone position. Anatomical identification by radioscopy: antero-posterior and sagittal planes. Needle placement in an anteroposterior view, needle is then advanced in an inclined plane of 20° with respect to the initial axis, "tunnel vision" type image. Foramen is then reached in a sagittal view (not to progress too far in the intra-foraminal level). Needle progression is secured by neurostimulation (territory concerned by the root, intensity 0.2 milliampere to be at a distance of 1mm from the nerve root). Once needle is in place, fluoroscopy is performed to verify correct positioning (Omnipaque 300mg/ml of Iohexol, 0.2 to 0.5ml). Once position confirmed, mixture Depomedrol 40mg + lidocaine 2% (1ml) is injected.

Device: Fluoroscopy guided periradicular lumbar infiltration

Interventions

Ultrasound guided periradicular lumbar infiltration DEVICE

Once position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle).

Ultrasound guided infiltration

Fluoroscopy guided periradicular lumbar infiltration DEVICE

Once position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle).

Fluoroscopy guided infiltration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• neurology, neurosurgery, physical medicine, algology consultation
• over the age of 18
• Radiculalgia in the territory corresponding to the root lesion
• Symptomatology inferior to two months.
• Imaging (CT scan or MRI) or electromyographic study with evidence (foraminal disc herniation or foraminal stenosis) of the irritation or the causal compression of the radicular symptomatology

You may not qualify if:

• allergy to any of the constituents of the infiltrated product, or to the contrast medium
• unstable medical condition: cardiac, respiratory, endocrine (uncontrolled diabetes)
• inability to put himself in a prone position
• depression: HADS score equal to or greater than 11.
• root lesion caused by an accident at work, a tumoral or infectious causal process.
• local infection (cutaneous, perimedullary / spinal) or systemic
• coagulopathy (platelets \<50000 / mm3, Prothrombin time \<60%, INTernational normalized ratio\> 1.5), anticoagulant or antiplatelet therapy treatment other than aspirin
• Lumbar surgical history
• history of foraminal or perimedullary infiltration of less than 6 months
• symptoms older than two months
• pregnant woman

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Hopital Erasme

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

Related Publications (5)

• Gangi A, Dietemann JL, Mortazavi R, Pfleger D, Kauff C, Roy C. CT-guided interventional procedures for pain management in the lumbosacral spine. Radiographics. 1998 May-Jun;18(3):621-33. doi: 10.1148/radiographics.18.3.9599387.

  PMID: 9599387 RESULT

• Galiano K, Obwegeser AA, Bodner G, Freund M, Maurer H, Kamelger FS, Schatzer R, Ploner F. Real-time sonographic imaging for periradicular injections in the lumbar spine: a sonographic anatomic study of a new technique. J Ultrasound Med. 2005 Jan;24(1):33-8. doi: 10.7863/jum.2005.24.1.33.

  PMID: 15615926 RESULT

• Obernauer J, Galiano K, Gruber H, Bale R, Obwegeser AA, Schatzer R, Loizides A. Ultrasound-guided versus computed tomography-controlled periradicular injections in the middle and lower cervical spine: a prospective randomized clinical trial. Eur Spine J. 2013 Nov;22(11):2532-7. doi: 10.1007/s00586-013-2916-0. Epub 2013 Jul 23.

  PMID: 23877110 RESULT

• Gofeld M, Bristow SJ, Chiu SC, McQueen CK, Bollag L. Ultrasound-guided lumbar transforaminal injections: feasibility and validation study. Spine (Phila Pa 1976). 2012 Apr 20;37(9):808-12. doi: 10.1097/BRS.0b013e3182340096.

  PMID: 21912311 RESULT

• Kim YH, Park HJ, Moon DE. Ultrasound-guided Pararadicular Injection in the Lumbar Spine: A Comparative Study of the Paramedian Sagittal and Paramedian Sagittal Oblique Approaches. Pain Pract. 2015 Nov;15(8):693-700. doi: 10.1111/papr.12249. Epub 2014 Oct 14.

  PMID: 25313534 RESULT

MeSH Terms

Conditions

Low Back Pain; Sciatica; Intervertebral Disc Displacement; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• Van Obbergh

  Chief of staff Anesthesiology

  STUDY DIRECTOR

Central Study Contacts

Gruson

CONTACT

0032 2 555 5850; paulgruson.dr@gmail.com

Van Obbergh

CONTACT

0032 2 555 5330

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, controlled, open trial

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: March 5, 2018
• Study Start: February 27, 2018
• Primary Completion: April 30, 2018
• Study Completion: May 30, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)