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Table 1 Treatment schedule and outcome measures

From: Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial

 

Study period

Enrollment

Allocation

Post allocation

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Timepoint

Screening

Visit1

Visit2

Visit3

Visit4

Visit5

Visit6

Visit7

Visit8

Visit9

Week

1

5

8

13

27

Enrollment

 Informed consent

X

          

 Sociodemographic profile

X

          

 Medical history

X

          

 Vital signs

X

X

X

X

X

X

X

X

   

 Inclusion/exclusion criteria

X

          

 Allocation

 

X

         

 Clinical laboratory tests

X

     

X

    

Interventions

 Acupuncture treatment

  

X

X

X

X

X

    

 Trial medication prescription

  

X

        

Assessments

 Change of medical history

  

X

X

X

X

X

X

X

X

X

 Safety assessment

  

X

X

X

X

X

X

   

 Visual Analog Scale of pain

  

X

   

X

X

   

 Foot and Ankle Outcome Score

  

X

   

X

X

   

 Edema of ankle sprain

  

X

   

X

X

   

 European Quality of Life 5-Dimension-5-Level Scale

  

X

   

X

X

  

X

 Number of recurrent ankle injuries

       

X

X

X

X