Clinical trial NCT03453775: Ultrasound-guided Lumbar Periradicular Injection: a Non Irradiating Infiltration Technique
Official title: Ultrasound-guided Lumbar Periradicular Injection: Effectiveness and Benefits of a Non Irradiating Infiltration Technique. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Sciatica
Disc, Herniated
Foraminal Hernia
Lumbar Foraminal Stenosis
Chronic Low Back Pain
Pain, Chronic
Injection Site Infiltration
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, open trial
Primary purpose: TREATMENT

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.

Detailed description: Foraminal periradicular infiltrations for therapeutic purposes are currently recognized as an integral part of the treatment of radiculalgia, particularly in case of radiculalgia refractory to a well-conducted initial treatment, in combination with the rehabilitation and education of the patient. The incidence of low back pain, lumbar pain or pure radiculalgia in the general population is very high. In fact, the majority of people will experience at least once in their life low back pain or neck pain, favored by the growing aging of the population. This leads us to propose infiltrative techniques more and more modern, as much in the technique performed as in the type of medication used, presenting the best risk / benefit ratio. Infiltrations guided by imaging tend to become less and less "invasive", with the undeniable contribution of ultrasound as a major tool in the diagnostic and therapeutic approaches, both in specialized pain management clinic as in other medical specialties. To date, infiltrations are still mostly performed under fluoroscopic control by injection of contrast medium (epidurography), or under CT control, where the identification of the anatomical structures and therefore the target allows a greater accuracy of the level of infiltration. These two techniques have proven their effectiveness, but have significant disadvantages, such as the irradiation of the patient as well as that of the practitioner because of the number of daily acts performed; their cost, and the need for a radiologist in the case of a CT technique. For its part, ultrasound is easily available, easy to use, represents a lower cost, and the lack of irradiation.

In recent years ultrasound has proved effective in identifying anatomical structures of the spine and in the techniques of lumbar periradicular infiltration, whether performed in sagittal paramedian or oblique sagittal paramedian, the latter having shown a better intra-foraminal distribution of the injected product. (39.5% vs 87.5% in terms of intraforaminal diffusion of the contrast medium). In addition, teams have shown the superiority of ultrasound-guided lumbar foraminal infiltration compared with CT control in terms of time spent on infiltration, for exact accuracy in 90% of patients, and an improvement in radiculalgia at 1 month similar between the two techniques.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effectiveness of needle placement under ultrasound guidance
timeFrame: Before infiltration
Secondary outcomes:
measure: Irradiation doses
timeFrame: 24h
measure: Visual analogue scale
timeFrame: Baseline, 2weeks, 4weeks
measure: Neuropathic pain score: DN4
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Oswestry Disability index
timeFrame: Baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Hopital Erasme
state: Bruxelles
Study officials:
affiliation: Chief of staff Anesthesiology
name: Van Obbergh
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.