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Table 1 Schedule of enrolment, interventions, and assessments

From: Transcutaneous auricular vagus nerve stimulation for the treatment of myoarthropatic symptoms in patients with craniomandibular dysfunction – a protocol for a randomized and controlled pilot trial

 

Study Period

 

Enrolment

Allocation

Post-Allocation

Close-out

TimePoint

-t1

Visit 0

Visit 1

Visit 2

Enrolment

    

Eligibility screen

x

   

Informed consent

x

   

Questionnaires

 

x

x

x

DC/TMD examination

x

x

x

x

Kinematics

 

x

x

x

EMG (Electromyography)

 

x

x

x

Allocation

 

x

  

Installation of digital protocol app on smartphone

 

x

  

Interventions:

    

Stimulation

    

Sham-Stimulation

    

Assessments:

    

Download stimulation diary from smartphone app

  

x

 

Baseline questionnaire

 

x

  

Baseline DC/TMD examination

x

x

  

Baseline EMG

 

x

  

Baseline Kinematics

 

x

  

Outcome questionnaires

  

x

x

Outcome DC/TMD examination

  

x

x

Outcome EMG

  

x

x

Outcome kinematics

  

x

x