NCT03168802 - 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)

Kaye EA, Monette S, Srimathveeravalli G, Maybody M, Solomon SB, Gulati A
MRI-guided focused ultrasound ablation of lumbar medial branch nerve: Feasibility and safety study in a swine model. Int J Hyperthermia. 2016 Nov;32(7):786-94. doi: 10.1080/02656736.2016.1197972. Epub 2016 Jul 21.
Krug R, Do L, Rieke V, Wilson MW, Saeed M
Evaluation of MRI protocols for the assessment of lumbar facet joints after MR-guided focused ultrasound treatment. J Ther Ultrasound. 2016 Apr 6;4:14. doi: 10.1186/s40349-016-0057-8. eCollection 2016.
Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW
Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2.
Weeks EM, Platt MW, Gedroyc W
MRI-guided focused ultrasound (MRgFUS) to treat facet joint osteoarthritis low back pain--case series of an innovative new technique. Eur Radiol. 2012 Dec;22(12):2822-35. doi: 10.1007/s00330-012-2628-6. Epub 2012 Aug 31.

Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain

Details for clinical trial NCT03168802

Clinical trial NCT03168802 - References