NCT05505981 - 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)

d'Hemecourt PA, Zurakowski D, d'Hemecourt CA, Curtis C, Ugrinow V, Deriu L, Micheli LJ
Validation of a new instrument for evaluating low back pain in the young athlete. Clin J Sport Med. 2012 May;22(3):244-8. doi: 10.1097/JSM.0b013e318249a3ce.
Klein G, Mehlman CT, McCarty M
Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.
Selhorst M, Allen M, McHugh R, MacDonald J
REHABILITATION CONSIDERATIONS FOR SPONDYLOLYSIS IN THE YOUTH ATHLETE. Int J Sports Phys Ther. 2020 Apr;15(2):287-300.
Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, MacDonald J
Long-Term Clinical Outcomes and Factors That Predict Poor Prognosis in Athletes After a Diagnosis of Acute Spondylolysis: A Retrospective Review With Telephone Follow-up. J Orthop Sports Phys Ther. 2016 Dec;46(12):1029-1036. doi: 10.2519/jospt.2016.7028. Epub 2016 Nov 8.
Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, Welder E, MacDonald J
Timing of Physical Therapy Referral in Adolescent Athletes With Acute Spondylolysis: A Retrospective Chart Review. Clin J Sport Med. 2017 May;27(3):296-301. doi: 10.1097/JSM.0000000000000334.
Selhorst M, MacDonald J, Martin LC, Rodenberg R, Krishnamurthy R, Ravindran R, Fischer A
Immediate functional progression program in adolescent athletes with a spondylolysis. Phys Ther Sport. 2021 Nov;52:140-146. doi: 10.1016/j.ptsp.2021.08.009. Epub 202

Back in the Game: An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis: A Multi-Center Randomized Pilot Trial

Details for clinical trial NCT05505981

Clinical trial NCT05505981 - References