NCT04930211 - 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)

Buttermann GR
The effect of spinal steroid injections for degenerative disc disease. Spine J. 2004 Sep-Oct;4(5):495-505.
Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Jensen TS, Manniche C
Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI. Eur Spine J. 2012 Nov;21(11):2271-9. doi: 10.1007/s00586-012-2309-9. Epub 2012 Apr 24.
Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M
15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6. Review.
Kjaer P, Korsholm L, Bendix T, Sorensen JS, Leboeuf-Yde C
Modic changes and their associations with clinical findings. Eur Spine J. 2006 Sep;15(9):1312-9. Epub 2006 Aug 9.

The Effectiveness of Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain Associated With Modic Type-1 Change

Clinical trial NCT04930211 - References