Table 1.
Trial process chart
Period | Inclusion | Treatment | Follow-up | |
---|---|---|---|---|
Assessment | Baseline | First | Second | Third |
Measure point | 0 weeks after inclusion | 4 weeks after inclusion | 6 weeks after inclusion | 8 weeks after inclusion |
Diagnosis and treatment | ||||
Inclusion confirmed | √ | |||
Informed consent | √ | |||
Body sign | √ | √ | ||
Disease history | √ | |||
Treatment history | √ | |||
Comorbidity | √ | √ | √ | √ |
Current treatment | √ | √ | √ | √ |
Pain condition and lumbar function assessment | ||||
Visual Analogue Scale | √ | √ | √ | √ |
Roland-Morris Disability Questionnaire | √ | √ | √ | √ |
McGill pain questionnaire | √ | √ | √ | √ |
Japanese Orthopedic Association Score | √ | √ | √ | √ |
Data collection and statistical analysis | ||||
Adverse event | √ | |||
Causes of dropout | √ | √ | √ | |
Safety analysis | √ | |||
Compliance analysis | √ | √ | √ | |
Health economics | √ |