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

Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain. Effectiveness and Benefits of a Non Irradiating Technique.

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 Overview

• Status: Unknown
• Conditions: Low Back Pain; Chronic Low Back Pain; Facet Joint Pain; Facet Syndrome of Lumbar Spine
• Intervention / Treatment: Procedure: Ultrasound-Guided Thermocoagulation of Lumbar facet joints; Procedure: Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht
    • Bruxelles, Anderlecht, Belgium, 1070
      • Recruiting
      • sebastian Jorquera Vasquez
      • Contact: sebastian Jorquera Vasquez, Medical Doctor; Phone Number: 0032 2 5555816; Email: cseb206@gmail.com
      • Contact: Turgay Tuna, Medical Doctor; Phone Number: 0032 2 5555413; Email: Turgay.Tuna@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of needle placement under ultrasound guidance	Good position: G. Wrong position: W.	Before infiltration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue scale	0/10 (minimum) to 10/10 (maximum)	Baseline, 6 weeks
Oswestry Disability index	% out of 50 questions (0/50= 0% to 50/50= 100%)	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Director: Luc Van Obbergh, PhD, Chief of staff Anesthesiology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Back Pain; Low Back Pain
• Other Study ID Numbers: P2017/552

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No