NCT03564418 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cohen SP, Raja SN
Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. Review.
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.
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.
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.
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.
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.

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

Clinical trial NCT03564418 - References