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

Primary Purpose

Low Back Pain, Sciatica, Disc, Herniated

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ultrasound guided periradicular lumbar infiltration
Fluoroscopy guided periradicular lumbar infiltration
Sponsored by
Université Libre de Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital ErasmeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound guided infiltration

Fluoroscopy guided infiltration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effectiveness of needle placement under ultrasound guidance
Good position: G. Wrong position: W.

Secondary Outcome Measures

Irradiation doses
centiGray. Radioscopy irradiation doses will be calculated in each procedure, to determine how efficient the ultrasound approach is, compared to fluoroscopy only.
Visual analogue scale
0/10 (minimum) to 10/10 (maximum)
Neuropathic pain score: DN4
Score /10
Oswestry Disability index
% out of 50 questions (0/50= 0% to 50/50=100%)

Full Information

First Posted
January 16, 2018
Last Updated
April 7, 2018
Sponsor
Université Libre de Bruxelles
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1. Study Identification

Unique Protocol Identification Number
NCT03453775
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
May 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Sciatica, Disc, Herniated, Foraminal Hernia, Lumbar Foraminal Stenosis, Chronic Low Back Pain, Pain, Chronic, Injection Site Infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled, open trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided infiltration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fluoroscopy guided infiltration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound guided periradicular lumbar infiltration
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Fluoroscopy guided periradicular lumbar infiltration
Intervention Description
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).
Primary Outcome Measure Information:
Title
Effectiveness of needle placement under ultrasound guidance
Description
Good position: G. Wrong position: W.
Time Frame
Before infiltration
Secondary Outcome Measure Information:
Title
Irradiation doses
Description
centiGray. Radioscopy irradiation doses will be calculated in each procedure, to determine how efficient the ultrasound approach is, compared to fluoroscopy only.
Time Frame
24h
Title
Visual analogue scale
Description
0/10 (minimum) to 10/10 (maximum)
Time Frame
Baseline, 2weeks, 4weeks
Title
Neuropathic pain score: DN4
Description
Score /10
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Oswestry Disability index
Description
% out of 50 questions (0/50= 0% to 50/50=100%)
Time Frame
Baseline, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gruson
Phone
0032 2 555 5850
Email
paulgruson.dr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Van Obbergh
Phone
0032 2 555 5330
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Van Obbergh
Organizational Affiliation
Chief of staff Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Erasme
City
Anderlecht
State/Province
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3225553111

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9599387
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.
Results Reference
result
PubMed Identifier
15615926
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.
Results Reference
result
PubMed Identifier
23877110
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.
Results Reference
result
PubMed Identifier
21912311
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.
Results Reference
result
PubMed Identifier
25313534
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.
Results Reference
result

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

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