NCT03564418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 11, 2018

Last Update Submit

June 11, 2018

Conditions

Low Back PainFacet Joint PainFacet Syndrome of Lumbar SpineChronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of needle placement under ultrasound guidance

    Good position: G. Wrong position: W.

    Before infiltration

Secondary Outcomes (2)

  • Visual Analogue scale

    Baseline, 6 weeks

  • Oswestry Disability index

    Baseline, 6 weeks

Study Arms (2)

Ultrasound-Guided Thermocoagulation of Lumbar facet joints

ACTIVE COMPARATOR

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

Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints

ACTIVE COMPARATOR

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

Interventions

Ultrasound-Guided Thermocoagulation of Lumbar facet jointsPROCEDURE

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.

Ultrasound-Guided Thermocoagulation of Lumbar facet joints
Fluoroscopy-Guided Thermocoagulation of Lumbar facet jointsPROCEDURE

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.

Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sebastian Jorquera Vasquez

Brussels, Anderlecht, 1070, Belgium

RECRUITING

Related Publications (7)

  • 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.

    PMID: 29234798BACKGROUND

  • 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.

    PMID: 17325518BACKGROUND

  • 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.

    PMID: 9430810BACKGROUND

  • 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.

    PMID: 28576500BACKGROUND

  • 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.

    PMID: 15114223RESULT

  • 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.

    PMID: 22977695RESULT

  • 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.

    PMID: 23467334RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luc Van Obbergh, PhD

    Chief of staff Anesthesiology

    STUDY DIRECTOR

Central Study Contacts

Sebastian D Jorquera Vasquez, Medical Doctor

CONTACT

0032 2 555 5816cseb206@gmail.com

Turgay Tuna, Medical Doctor

CONTACT

032 2 555 5413Turgay.Tuna@erasme.ulb.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, Controlled, Open trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 20, 2018

Study Start

January 2, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

BE(1)