Comparison of two types of platelet-rich plasma in rotator cuff injury: study protocol for a randomized clinical trial

Background Platelet-rich plasma (PRP) has been widely used in the treatment of rotator cuff tendinopathy. Due to the lack of unified standards for PRP preparation and clinical instructions, its efficacy remains controversial. Purpose We aimed to conduct a pragmatic comparison of two commonly used composite PRP formulations with different platelet (PLT) and leukocyte concentrations to provide clinical evidence for the optimal PRP formulation in the treatment of rotator cuff injury (RCI). Methods A prospective, single-center, participant-blinded, outcome-assessor-blinded, and statistician-blinded randomized controlled trial with a 12-month follow-up investigating PRP in RCI will be conducted at Southwest Medicine University. Participants who choose PRP treatment will be randomly allocated in a 1:1 ratio to either group. Clinical assessments will be performed at baseline (2 days before PRP injection) and 1, 3, 6, and 12 months after the first injection. The primary outcomes include the Chinese version of the Constant-Murley Score (CMS) and the visual analog scale (VAS). Secondary outcomes include imaging changes assessed by magnetic resonance imaging (MRI) and ultrasound (US) scanning, serum cytokine measurements, the 12-Item Short Form (SF-12), and adverse events (AEs). Statistical analysis will be performed according to the intention-to-treat (ITT) principle. Implications The results will provide new evidence for the optimal PRP formulation for RCI in clinical practice. Furthermore, we will investigate multiple outcomes, including clinical, functional, structural, and inflammatory changes after PRP injection. Trial registration https://www.chictr.org.cn/searchproj.html?title=&officialname=&subjectid=&regstatus=&regno=ChiCTR2500113374&secondaryid=&applier=&studyleader=&createyear=&sponsor=&secsponsor=&sourceofspends=&studyailment=&studyailmentcode=&studytype=&studystage=&studydesign=&recruitmentstatus=&gender=&agreetosign=&measure=&country=&province=&city=&institution=&institutionlevel=&intercode=&ethicalcommitteesanction=&whetherpublic=&minstudyexecutetime=&maxstudyexecutetime=&btngo=btn , This study was registered in the Chinese clinical trial registry (ChiCTR2500113374).