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Table 1 Schedule for the treatment and outcome measurements

From: Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial

Visit

S

1

2

3

4

5

6

7

8

Week

1

2

 

3

4

Informed consent

        

Demographic characteristics

        

Vital signs

Blood test

       

Medical history

        

Inclusion/Exclusion criteria

        

Conformity assessment

        

Treatment expectancy questionnaire

        

Random allocation

 

       

Treatment

 

Prescription of rescue medicine

 

       

PI-NRS

 

NDI

 

      

CROM

 

      

HRV

 

      

Perceived stress scale

 

      

EQ-5D

 

      

PGIC

        

Pressure pain threshold

 

      

Consumption of rescue medicine

        

Days of restricted activity

 

      

Blinding test

 

      

Safety assessment

 

  1. Visit 1: within 4 weeks after screening, Visit 8: 4 weeks after Visit 1 (+6 days)
  2. CROM Cervical Range of Motion, NDI Neck Disability Index; PGIC Patient Global Impression of Change, PI-NRS 11-point Pain Intensity Numerical Rating Scale, S screening visit