Table 2.
Flow chart of study.
| Study period | |||||
|---|---|---|---|---|---|
| Recruitment | Intervention period | Observation period | |||
| Visit | Screening | V1 Before intervention |
V1 After intervention |
V2-V6 | V7 |
| Checking the selection/exclusion criteria | ● | ||||
| Vital signs | ● | ● | ● | ● | |
| Demographic surveys and body measurements | ● | ||||
| Medical history of lumbar and other body organs | ● | ||||
| Lumbar spine X-ray and computed tomography (CT) | ● | ||||
| Physical examination | ● | ||||
| Random assignment | ● | ||||
| Treatment (Orthopedic or sham device) | ● | ● | |||