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Table 3 Schedule of enrollment, interventions, and assessments during the present study according to SPIRIT [40]

From: Is radial extracorporeal shock wave therapy combined with a specific rehabilitation program (rESWT + RP) more effective than sham-rESWT + RP for acute hamstring muscle complex injury type 3b in athletes? Study protocol for a prospective, randomized, double-blind, sham-controlled single centre trial

Timepoint

Study period

Enrollment/Allocation

Post-allocation

Follow-up

Close-out

D0, D1, or D2

D0-D3 or D1-D4 or D2-D5

D5, D7, D9, D12, D14, D16, D19, D21, and D23

D5–D60

Between D5 and M6

M6

Enrollment

 Clinical evaluation

X

     

 Ultrasonographic evaluation

X

     

 Eligibility screen

X

     

 Allocation

X

     

Interventions

 RICE

 

X

    

 rESWT

  

X

   

 sham-rESWT

  

X

   

 RP

   

X

  

Assessments

 A, G, BMI, S, P, SG

X

     

 Individual time to return to play

    

X

 

 Secondary endpoints

     

X

  1. D day; M month; RICE rest, ice, compression, and elevation; rESWT radial extracorporeal shock wave therapy; RP rehabilitation program; A age; G gender; BMI body mass index; S sport that is practiced; P position in the field; SG sporting gesture that caused an injury; D day; M month
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Journal of Orthopaedic Surgery and Research

ISSN: 1749-799X