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Table 2 Timetable of enrolment, interventions, and assessments

From: Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial

 

Study period

Baseline

Allocation

Treatment

Follow-up phase

Visit

 

1

2

3

4

5

Timepoint (week)

− 4

0

1–4

5–8

9–12

13–16

Enrolment:

 Eligibility screen

X

X

    

 Informed consent

 

X

    

 Demographic characteristics

 

X

    

 Treatment history

 

X

    

 Combined diseases and medication

 

X

X

X

X

X

 Information of migraine

 

X

X

X

X

X

 Randomization

 

X

    

 Allocation

 

X

    

Interventions:

 Manual acupuncture

  

X

   

 Placebo acupuncture

  

X

   

Assessments:

 Headache diary

 

X

X

X

X

X

 Visual analog scale

 

X

X

X

X

X

 Migraine-specific Quality-of-Life Questionnaire Life Questionnaire (MSQ)

 

X

X

X

X

X

 Headache impact test-6 (HIT-6)

 

X

X

X

X

X

 Acupuncture Expectancy Questionnaire

 

X

    

 Neuropeptide calcitonin gene-related peptide (CGRP)

 

X

X

  

X

 Blinding for group allocation

     

X

 Safety assessment

 

X

X

X

X

X

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Trials

ISSN: 1745-6215