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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound-guided Lumbar Periradicular Injection: Effectiveness and Benefits of a Non Irradiating Infiltration Technique. A Randomized Controlled Trial

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

Intervention / Treatment
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* Device: Ultrasound guided periradicular lumbar infiltration
* Device: Fluoroscopy guided periradicular lumbar infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, open trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guided infiltration<br>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<br>* 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).<br>|
| Active Comparator: Fluoroscopy guided infiltration<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of needle placement under ultrasound guidance | Good position: G. Wrong position: W. | Before infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irradiation doses | centiGray. Radioscopy irradiation doses will be calculated in each procedure, to determine how efficient the ultrasound approach is, compared to fluoroscopy only. | 24h | 
| Visual analogue scale | 0/10 (minimum) to 10/10 (maximum) | Baseline, 2weeks, 4weeks | 
| Neuropathic pain score: DN4 | Score /10 | Baseline, 2 weeks, 4 weeks | 
| Oswestry Disability index | % out of 50 questions (0/50= 0% to 50/50=100%) | Baseline, 2 weeks, 4 weeks |