Muscle Injury RTP Design in Football; Effects of Backward Design vs Forward Design.

Introduction "Return-to-play" (RTP) is an English term that corresponds to "return to competition". It is important to understand that this return is a constant, dynamic, and personalized decision-making process . The main objective of RTP is not to predict the exact moment of an athlete's return; rather, it is to prevent new injuries. For this, adequate decision-making is necessary. There are several important steps in the process, including correct diagnosis, strict control of workloads, and intelligent management of modifiers intrinsic to the sport that can lead to anxiety and stress How are the pieces of the RTP puzzle arranged and managed? How are RTP processes evaluated today? How should RTP be understood? Should it be understood statically, as a checklist, or as a constant decision-making process involving the player? Main objective: Evaluate the design of the RTP process for muscle injuries in sports. Specific objectives: * To compare two RTP designs and evaluate how their design influences the anxiety experienced by the player. * Identify variables that may be altered when choosing a regressive or progressive RTP design, such as sleep quality and cortisol level. * To establish direction in the design of the RTP process. * Create complete clinical guidelines on muscle injuries in sports with a focus on RTP design. Material and Methods Definition of the Study Subjects The subjects of the study will be all players belonging to the first or B team who suffer a muscle injury diagnosed by magnetic resonance imaging. At the time of injury, they will be randomly assigned to either the control group (following a regressive RTP design) or the intervention group (following a progressive RTP design). Masking will be double-blind. The sample size will be N=74. The secondary variables will be recorded in the database after diagnosis by MRI. Subsequently, the primary variables will be measured and recorded at the beginning, middle, and end of the RTP period. It is estimated that approximately half of the necessary sample size has been reached: about 37 subjects with muscle injury. The first statistical analysis will then be carried out to observe the preliminary results. After three years, once the analysis has been completed, the results and conclusions will be written up for publication in a journal.

NCT Number	NCT07012408
Lead Sponsor	Universitat de les Illes Balears
Conditions	Muscle Injuries, Football Players
Enrollment	74 participants
Start Date	2025-09-01
Primary Completion	2027-03-03 (estimated)
Study Completion	2028-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-18