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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453775
• Other study ID #: P2018/047
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2018
• Last updated: April 7, 2018
• Start date: February 27, 2018
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2018
• Source: Université Libre de Bruxelles
• Contact: Gruson
• Phone: 0032 2 555 5850
• Email: paulgruson.dr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Pain
• Disc, Herniated
• Foraminal Hernia
• Injection Site Infiltration
• Intervertebral Disc Displacement
• Low Back Pain
• Lumbar Foraminal Stenosis
• Pain, Chronic
• Sciatica

Intervention

Device:
• Ultrasound guided periradicular lumbar infiltration
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 periradicular lumbar infiltration
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).

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Anderlecht	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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- — View 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. — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of needle placement under ultrasound guidance	Good position: G. Wrong position: W.	Before infiltration
Secondary	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
Secondary	Visual analogue scale	0/10 (minimum) to 10/10 (maximum)	Baseline, 2weeks, 4weeks
Secondary	Neuropathic pain score: DN4	Score /10	Baseline, 2 weeks, 4 weeks
Secondary	Oswestry Disability index	% out of 50 questions (0/50= 0% to 50/50=100%)	Baseline, 2 weeks, 4 weeks