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

Primary Purpose

Low Back Pain, Facet Joint Pain, Facet Syndrome of Lumbar Spine

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ultrasound-Guided Thermocoagulation of Lumbar facet joints
Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

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

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.

Sites / Locations

  • sebastian Jorquera VasquezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound-Guided Thermocoagulation of Lumbar facet joints

Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analogue scale
0/10 (minimum) to 10/10 (maximum)
Oswestry Disability index
% out of 50 questions (0/50= 0% to 50/50= 100%)

Full Information

First Posted
June 11, 2018
Last Updated
June 11, 2018
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03564418
Brief Title
Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain.
Official Title
Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain. Effectiveness and Benefits of a Non Irradiating Technique.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Facet Joint Pain, Facet Syndrome of Lumbar Spine, Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Controlled, Open trial.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-Guided Thermocoagulation of Lumbar facet joints
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Thermocoagulation of Lumbar facet joints
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints
Intervention Description
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.
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
Visual Analogue scale
Description
0/10 (minimum) to 10/10 (maximum)
Time Frame
Baseline, 6 weeks
Title
Oswestry Disability index
Description
% out of 50 questions (0/50= 0% to 50/50= 100%)
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian D Jorquera Vasquez, Medical Doctor
Phone
0032 2 555 5816
Email
cseb206@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Turgay Tuna, Medical Doctor
Phone
032 2 555 5413
Email
Turgay.Tuna@erasme.ulb.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Van Obbergh, PhD
Organizational Affiliation
Chief of staff Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
sebastian Jorquera Vasquez
City
Bruxelles
State/Province
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sebastian Jorquera Vasquez, Medical Doctor
Phone
0032 2 5555816
Email
cseb206@gmail.com
First Name & Middle Initial & Last Name & Degree
Turgay Tuna, Medical Doctor
Phone
0032 2 5555413
Email
Turgay.Tuna@erasme.ulb.ac.be

12. IPD Sharing Statement

Citations:
PubMed Identifier
29234798
Citation
Rimmalapudi V, Buchalter J, Calodney A. Radiofrequency Denervation for Chronic Low Back Pain. JAMA. 2017 Dec 12;318(22):2255-2256. doi: 10.1001/jama.2017.16378. No abstract available.
Results Reference
background
PubMed Identifier
17325518
Citation
Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
Results Reference
background
PubMed Identifier
9430810
Citation
Fukui S, Ohseto K, Shiotani M, Ohno K, Karasawa H, Naganuma Y. Distribution of referred pain from the lumbar zygapophyseal joints and dorsal rami. Clin J Pain. 1997 Dec;13(4):303-7. doi: 10.1097/00002508-199712000-00007.
Results Reference
background
PubMed Identifier
28576500
Citation
Lee CH, Chung CK, Kim CH. The efficacy of conventional radiofrequency denervation in patients with chronic low back pain originating from the facet joints: a meta-analysis of randomized controlled trials. Spine J. 2017 Nov;17(11):1770-1780. doi: 10.1016/j.spinee.2017.05.006. Epub 2017 May 30.
Results Reference
background
PubMed Identifier
15114223
Citation
Greher M, Scharbert G, Kamolz LP, Beck H, Gustorff B, Kirchmair L, Kapral S. Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Anesthesiology. 2004 May;100(5):1242-8. doi: 10.1097/00000542-200405000-00028.
Results Reference
result
PubMed Identifier
22977695
Citation
Jung H, Jeon S, Ahn S, Kim M, Choi Y. The validation of ultrasound-guided lumbar facet nerve blocks as confirmed by fluoroscopy. Asian Spine J. 2012 Sep;6(3):163-7. doi: 10.4184/asj.2012.6.3.163. Epub 2012 Aug 21.
Results Reference
result
PubMed Identifier
23467334
Citation
Kim D, Choi D, Kim C, Kim J, Choi Y. Transverse process and needles of medial branch block to facet joint as landmarks for ultrasound-guided selective nerve root block. Clin Orthop Surg. 2013 Mar;5(1):44-8. doi: 10.4055/cios.2013.5.1.44. Epub 2013 Feb 20.
Results Reference
result

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

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