Table 2.
Data elements | Therapeutic Session | Follow-up Period | |||||||
---|---|---|---|---|---|---|---|---|---|
Minimum treatmenta | … | Last Visit | Minimum follow-upb | … | |||||
First Visit | Second Visit | Thirdly Visit | Week 1 | Week 12 | Week 24 | ||||
Demographic information | ✓ | ||||||||
CLBP information | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Diagnosis | ✓ | ||||||||
Lumbar imaging | ✓ | ||||||||
Informed Consent | ✓ | ||||||||
Acupuncture rationale | ✓ | ||||||||
Acupuncture details | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Acupuncture regimen | ✓ | ||||||||
Combined therapy | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Numerical Rating scale (NRS) | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Oswestry Disability Index (ODI) | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Adverse event | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Disease status | ✓ | ✓ | ✓ | ✓ |
aThe number of acupuncture treatments shall be no less than three times, bNo less than three follow-up visits