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Trial record 17 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

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

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ClinicalTrials.gov Identifier: NCT03453775
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Gruson, Université Libre de Bruxelles

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Sciatica Disc, Herniated Foraminal Hernia Lumbar Foraminal Stenosis Chronic Low Back Pain Pain, Chronic Injection Site Infiltration Device: Ultrasound guided periradicular lumbar infiltration Device: Fluoroscopy guided periradicular lumbar infiltration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, open trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Lumbar Periradicular Injection: Effectiveness and Benefits of a Non Irradiating Infiltration Technique. A Randomized Controlled Trial
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Ultrasound guided infiltration
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
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).

Active Comparator: Fluoroscopy guided infiltration
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
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 Measures :
  1. Effectiveness of needle placement under ultrasound guidance [ Time Frame: Before infiltration ]
    Good position: G. Wrong position: W.


Secondary Outcome Measures :
  1. Irradiation doses [ Time Frame: 24h ]
    centiGray. Radioscopy irradiation doses will be calculated in each procedure, to determine how efficient the ultrasound approach is, compared to fluoroscopy only.

  2. Visual analogue scale [ Time Frame: Baseline, 2weeks, 4weeks ]
    0/10 (minimum) to 10/10 (maximum)

  3. Neuropathic pain score: DN4 [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Score /10

  4. Oswestry Disability index [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    % out of 50 questions (0/50= 0% to 50/50=100%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453775


Contacts
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Contact: Gruson 0032 2 555 5850 paulgruson.dr@gmail.com
Contact: Van Obbergh 0032 2 555 5330

Locations
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Belgium
Hopital Erasme Recruiting
Anderlecht, Bruxelles, Belgium, 1070
Contact    +3225553111      
Sponsors and Collaborators
Université Libre de Bruxelles
Investigators
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Study Director: Van Obbergh Chief of staff Anesthesiology

Publications of Results:
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Responsible Party: Paul Gruson, Principal Investigator, Université Libre de Bruxelles
ClinicalTrials.gov Identifier: NCT03453775     History of Changes
Other Study ID Numbers: P2018/047
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Intervertebral Disc Displacement
Sciatica
Neurologic Manifestations
Signs and Symptoms
Hernia
Pathological Conditions, Anatomical
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants