Table 2.
Study schedule of clinical trial (6 months)
| |
Initial screening |
Treatment times |
Follow-up |
|||
|---|---|---|---|---|---|---|
| |
Visit 1 |
Visit 2 |
Visit 3 |
Visit 4 |
Visit 5 |
Visit 6 |
| Week 0 | Week 1 | Week 2 | Week 4 | Month 2 | Month 5 | |
| Determined the exclusion criteria |
Yes |
|
|
|
|
|
| Informed consent |
Yes |
|
|
|
|
|
| Randomized |
Yes |
|
|
|
|
|
| Weight |
Yes |
|
Yes |
Yes |
|
|
| Blood pressure |
Yes |
|
Yes |
Yes |
|
|
| Heart rate/Rhythm |
Yes |
|
Yes |
Yes |
|
|
| Respiratory rate |
Yes |
|
Yes |
Yes |
|
|
| Spurling’s test |
Yes |
|
|
|
|
|
| Brachial plexus force test |
Yes |
|
|
|
|
|
| Drug allergy history |
Yes |
|
|
|
|
|
| Blood routine |
Yes |
|
|
Yes |
|
|
| Urine routine |
Yes |
|
|
Yes |
|
|
| Excrement routine |
Yes |
|
|
Yes |
|
|
| Occult blood |
Yes |
|
|
Yes |
|
|
| ECG |
Yes |
|
|
Yes |
|
|
| Liver function test |
Yes |
|
|
Yes |
|
|
| Kidney function test |
Yes |
|
|
Yes |
|
|
| X-ray (frontal and lateral) |
Yes |
|
|
Yes |
|
|
| Concomitant medication |
|
Yes |
Yes |
Yes |
|
|
| VAS scores |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| NDI scores |
Yes |
|
Yes |
Yes |
Yes |
Yes |
| SF-36 scores |
|
Yes |
Yes |
Yes |
|
|
| The medicine issue |
|
Yes |
Yes |
|
|
|
| Compliance assessment |
|
|
Yes |
Yes |
|
|
| Degree of satisfaction |
|
|
|
Yes |
|
|
| Safety evaluation | Yes | Yes | ||||
ECG: Electrocardiogram; VAS: Visual analogue scale; NDI: Neck disability index: SF-36: The MOS item short from health survey.