Period | Inclusion | Treatment | Follow-up | |
---|---|---|---|---|
Assessment | Baseline | First | Second | Third |
Measure point | 0Â weeks after inclusion | 4Â weeks after inclusion | 6Â weeks after inclusion | 8Â 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 |  | √ |  |  |