Table 1.
Period |
S |
T |
P |
||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
Week | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 17 | |||||||||
Informed consent |
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Demographic characteristics |
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inclusion/Exclusion criteria |
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conformity assessment |
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood test |
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vital signs |
● |
● |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
● |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
● |
● |
Medical history |
● |
● |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
● |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
● |
● |
Treatment expectancy questionnaire |
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blinding test |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
○ |
|
|
Random allocation |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Treatment |
|
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
|
|
PI-NRS |
● |
● |
|
|
|
|
|
|
|
● |
|
|
|
|
|
|
|
● |
● |
SF-MPQ |
|
● |
|
|
|
|
|
|
|
● |
|
|
|
|
|
|
|
● |
● |
Sleep disturbance score |
|
● |
|
|
|
|
|
|
|
● |
|
|
|
|
|
|
|
● |
● |
SF-36 |
|
● |
|
|
|
|
|
|
|
● |
|
|
|
|
|
|
|
● |
● |
Beck Depression Inventory |
|
● |
|
|
|
|
|
|
|
● |
|
|
|
|
|
|
|
● |
● |
PGIC |
|
● |
|
|
|
|
|
|
|
● |
|
|
|
|
|
|
|
● |
● |
Safety assessment | ● | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ● | ● |
P post-treatment phase, PGIC Patient Global Impression of Change, PI-NRS 11-point Pain Intensity Numerical Rating Scale, S screening phase, SF-36 Short-Form 36v2 Health Survey, SF-MPQ Short-Form McGill Pain Questionnaire, T treatment phase, ● All groups, ○ Both the electroacupuncture and sham group.