Low Back Pain Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | sebastian Jorquera Vasquez | Bruxelles | Anderlecht |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium,
Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of needle placement under ultrasound guidance | Good position: G. Wrong position: W. | Before infiltration | |
Secondary | Visual Analogue scale | 0/10 (minimum) to 10/10 (maximum) | Baseline, 6 weeks | |
Secondary | Oswestry Disability index | % out of 50 questions (0/50= 0% to 50/50= 100%) | Baseline, 6 weeks |
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