NCT04640662 - 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)

1
Littlewood, C., S. May, and S. Walters, Epidemiology of Rotator Cuff Tendinopathy: A Systematic Review. Shoulder & Elbow, 2013. 5(4): p. 256-265.
Docheva D, Müller SA, Majewski M, Evans CH
Biologics for tendon repair. Adv Drug Deliv Rev. 2015 Apr;84:222-39. doi: 10.1016/j.addr.2014.11.015. Epub 2014 Nov 21. Review.
Hurley ET, Hannon CP, Pauzenberger L, Fat DL, Moran CJ, Mullett H
Nonoperative Treatment of Rotator Cuff Disease With Platelet-Rich Plasma: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2019 May;35(5):1584-1591. doi: 10.1016/j.arthro.
Lewis J, McCreesh K, Roy JS, Ginn K
Rotator Cuff Tendinopathy: Navigating the Diagnosis-Management Conundrum. J Orthop Sports Phys Ther. 2015 Nov;45(11):923-37. doi: 10.2519/jospt.2015.5941. Epub 2015 Sep 21. Review.
Lin MT, Chiang CF, Wu CH, Huang YT, Tu YK, Wang TG
Comparative Effectiveness of Injection Therapies in Rotator Cuff Tendinopathy: A Systematic Review, Pairwise and Network Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Feb;100(2):336-349.e15. doi: 10.1016/j.apmr.2018.06.028. Epub 2018 Aug 2.
Trebinjac S and Kitchbi
Long-term effect of Prolotherapy on symptomatic rotator cuff tendinopathy. Journal of Health Sciences 2015;5(3):93-98

The Effects of Platelet Rich Plasma Versus Prolotherapy on Pain and Function in Rotator Cuff Tendinopathy: A Randomized Clinical Trial

Clinical trial NCT04640662 - References