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Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain.

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ClinicalTrials.gov Identifier: NCT03564418
Recruitment Status : Unknown
Verified June 2018 by Erasme University Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Study Description
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Brief Summary:
We propose here to evaluate the precision of lumbar thermocoagulation 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 six weeks post-thermocoagulation: the Visual analogue pain Scale score (VAS) and the Oswestry disability score (ODI) will be collected, compared to that of the conventional fluoroscopic technique.

Condition or disease Intervention/treatment Phase
Low Back Pain Facet Joint Pain Facet Syndrome of Lumbar Spine Chronic Low Back Pain Procedure: Ultrasound-Guided Thermocoagulation of Lumbar facet joints Procedure: Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints Not Applicable

Detailed Description:

Low back pain affects 70 to 80% of people at least once in their lives. They have considerable socio-economic repercussions and represent the leading medical cause of work stoppage, at around 25% .1

The articular pain between the lumbar vertebrae, called facet joints pain, represent between 15 and 45% of all low back pain and their manifestations are grouped under the name of facet syndrome including localized pains at the lumbar level as well as pains referred to the gluteal, trochanteric, inguinal and lateral and posterior region of the thigh. 2-5 The thermocoagulation of the roots innervating the lumbar facets consists in creating a lesion of the nerve roots innervating these articulations in order to block the transmission of the pain.

According to many studies this technique gives good results in 70 to 80% of the cases with an improvement around 71% to more than six months. 6 A recent Meta-analysis involving 454 patients also shows a significant improvement at 12 months of thermocoagulation versus placebo and even versus epidural lumbar. 7

To date, Lumbar Thermocoagulation are still mostly performed under fluoroscopic control by injection of contrast. This technique have proved this 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 and its cost.

For its part, ultrasound is easily available, easy to use, represents a lower cost, and the lack of irradiation. The technique to reach the lumbar facet joints with sonography is pretty well described and known for many years. 8

We propose here to evaluate the precision of lumbar thermocoagulation 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 six weeks post-thermocoagulation: the Visual analogue pain Scale score (VAS) and the Oswestry disability score (ODI) will be collected, compared to that of the conventional fluoroscopic technique.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Controlled, Open trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain. Effectiveness and Benefits of a Non Irradiating Technique.
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ultrasound-Guided Thermocoagulation of Lumbar facet joints
Prone position: Thanks to a high-resolution ultrasound and a 5 MHz curved probe, we will use the ultrasound technique described by Greher et al to reach the target points. Then, in order to check the correct positioning of the needles, we will inject 1 ml of a solution of contrast medium (omnipaque® 300 mg / ml of Iohexol) to observe them using the standard Fluoroscopic method. Wrongly positioned needles will be correctly repositioned and these patients will be excluded from ODI and VAS scale statistics.
 Procedure: Ultrasound-Guided Thermocoagulation of Lumbar facet joints

Prone position: Thanks to a high-resolution ultrasound and a 5 MHz curved probe, we will use the ultrasound technique described by Greher et al to reach the target points.

Then, in order to check the correct positioning of the needles, we will inject 1 ml of a solution of contrast medium (omnipaque® 300 mg / ml of Iohexol) to observe them using the standard Fluoroscopic method. Wrongly positioned needles will be correctly repositioned and these patients will be excluded from ODI and VAS scale statistics.

To ensure the effectiveness of the injury by thermocoagulation, sensory electrical stimulation is performed to confirm that the needle is close to the posterior ramus (50Hz, 0-3 volts) and another electrical stimulation is performed to confirm that there is no motor stimulation (2Hz, 0-3 volts). After injecting 1 ml of 2% linisol® through the needle, denervation of the facet will be performed with an electrode at 68 ° C for 90 seconds.
Active Comparator: Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints
Prone position: We will use the standard fluoroscopic method to reach the target points. (maximum three levels, same side). Then, in order to check the correct positioning of the needles, we will inject 1 ml of a solution of contrast medium (omnipaque® 300 mg / ml of Iohexol). The correct location being the superolateral edge of the lateral facet and the diffusion of the contrast material at the level of the medial branch observed thanks to an anteroposterior radioscopic view. Then the location of the needles is confirmed by a lateral radioscopic view.
 Procedure: Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints

Prone position: We will use the standard fluoroscopic method to reach the target points. (maximum three levels, same side). Then, in order to check the correct positioning of the needles, we will inject 1 ml of a solution of contrast medium (omnipaque® 300 mg / ml of Iohexol). The correct location being the superolateral edge of the lateral facet and the diffusion of the contrast material at the level of the medial branch observed thanks to an anteroposterior radioscopic view. Then the location of the needles is confirmed by a lateral radioscopic view.

To ensure the effectiveness of the injury by thermocoagulation, sensory electrical stimulation is performed to confirm that it is close to the posterior ramus (50Hz, 0-3 volts) and another electrical stimulation is performed to confirm that there is no motor stimulation (2Hz, 0-3 volts). After injecting 1 ml of 2% linisol® through the needle, denervation of the facet will be performed with an electrode at 68 ° C for 90 seconds.


Outcome Measures
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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. Visual Analogue scale [ Time Frame: Baseline, 6 weeks ]
    0/10 (minimum) to 10/10 (maximum)

  2. Oswestry Disability index [ Time Frame: Baseline, 6 weeks ]
    % out of 50 questions (0/50= 0% to 50/50= 100%)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the age of 18.
  • Facet Syndrome.
  • Symptomatology superior than 3 mounths.
  • A failure of conservative treatement (drugs, physiotherapy...)
  • Partial improvement after two lumbar facet infiltrations.

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)
  • 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 arthrodesis.
  • Neurological condition affecting motor function (Stroke, Parkinson...)
  • Pregnant woman.
Contacts and Locations
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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): NCT03564418


Contacts
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Contact: Sebastian D Jorquera Vasquez, Medical Doctor 0032 2 555 5816 cseb206@gmail.com
Contact: Turgay Tuna, Medical Doctor 032 2 555 5413 Turgay.Tuna@erasme.ulb.ac.be

Locations
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Belgium
sebastian Jorquera Vasquez Recruiting
Bruxelles, Anderlecht, Belgium, 1070
Contact: sebastian Jorquera Vasquez, Medical Doctor    0032 2 5555816    cseb206@gmail.com   
Contact: Turgay Tuna, Medical Doctor    0032 2 5555413    Turgay.Tuna@erasme.ulb.ac.be   
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Study Director: Luc Van Obbergh, PhD Chief of staff Anesthesiology
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03564418    
Other Study ID Numbers: P2017/552
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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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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Arthralgia
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Joint Diseases
Musculoskeletal Diseases