NCT03644810 - 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)

Corrêa JB, Costa LO, de Oliveira NT, Sluka KA, Liebano RE
Central sensitization and changes in conditioned pain modulation in people with chronic nonspecific low back pain: a case-control study. Exp Brain Res. 2015 Aug;233(8):2391-9. doi: 10.1007/s00221-
Edwards RR, Smith MT, Stonerock G, Haythornthwaite JA
Pain-related catastrophizing in healthy women is associated with greater temporal summation of and reduced habituation to thermal pain. Clin J Pain. 2006 Oct;22(8):730-7.
Meints S and Edwards R
Altered pain sensitivity in patients with chronic low back pain. The Journal of Pain 2018;19:S57 (In Press)
Mlekusch S, Neziri AY, Limacher A, Jüni P, Arendt-Nielsen L, Curatolo M
Conditioned Pain Modulation in Patients With Acute and Chronic Low Back Pain. Clin J Pain. 2016 Feb;32(2):116-21. doi: 10.1097/AJP.0000000000000238.
Vaegter HB, Palsson TS, Graven-Nielsen T
Facilitated Pronociceptive Pain Mechanisms in Radiating Back Pain Compared With Localized Back Pain. J Pain. 2017 Aug;18(8):973-983. doi: 10.1016/j.jpain.2017.03.002. Epub 2017 Mar 24.

The Efficiency of Conditioned Pain Modulation is Associated With Levels of Pain Catastrophizing in Patients With Chronic Low Back Pain

Clinical trial NCT03644810 - References