NCT03282695 - 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)

Hansson E, Hansson T
The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.
Luhmann D, Burkhardt-Hammer T, Borowski C, Raspe H
Minimally invasive surgical procedures for the treatment of lumbar disc herniation. GMS Health Technol Assess. 2005 Nov 15;1:Doc07.
Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET
Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.
Sherman J, Cauthen J, Schoenberg D, Burns M, Reaven NL, Griffith SL
Economic impact of improving outcomes of lumbar discectomy. Spine J. 2010 Feb;10(2):108-16. doi: 10.1016/j.spinee.2009.08.453. Epub 2009 Oct 12. Erratum In: Spine J. 2010 May;10(5):A8.
Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN
The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.

Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study

Clinical trial NCT03282695 - References