Table 1.
|
Period |
S |
|
|
|
|
|
|
T |
|
|
|
|
|
|
F |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Visit |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Week | 1 | 1 | 1 | 2 | 2 | 2 | 3 | 3 | 3 | 4 | 4 | 4 | 5 | 13 | ||
Informed Consent |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Demographic Characteristics |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical History |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Knee X-Ray |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inclusion/Exclusion Criteria |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conformity Assessment |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Treatment Expectancy Questionnaire |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood Test |
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
● |
|
Vital Signs |
|
● |
● |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
● |
● |
Change in Medical History |
|
|
● |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
● |
● |
Random Allocation |
|
|
● |
|
|
|
|
|
|
|
|
|
|
|
|
|
Moxibustion Treatment |
|
|
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
|
|
K-WOMAC |
|
|
● |
|
|
|
|
|
|
|
|
|
|
|
● |
● |
Beck Depression Inventory |
|
|
● |
|
|
|
|
|
|
|
|
|
|
|
● |
● |
The Short-Form 36v2 Health Survey |
|
|
● |
|
|
|
|
|
|
|
|
|
|
|
● |
● |
Pain Numerical Rating Scale |
|
● |
● |
|
|
|
|
|
|
|
|
|
|
|
● |
● |
Physical Function Test |
|
|
● |
|
|
|
|
|
|
|
|
|
|
|
● |
● |
Patient Global Assessment |
|
|
● |
|
|
|
|
|
|
|
|
|
|
|
● |
● |
Safety Assessment | ● | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ● | ● |
S: Screening Period, T: Treatment Period, F: Follow-up Period, K-WOMAC: Korean Western Ontario and McMaster Osteoarthritis Index, ●: Both the moxibustion group and the usual care group, ○: Only the moxibustion group.