| Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post allocation | Close-out | ||||||||
Timepoint | Screening | Visit1 | Visit2 | Visit3 | Visit4 | Visit5 | Visit6 | Visit7 | Visit8 | Visit9 | |
Week | 1 | 5 | 8 | 13 | 27 | ||||||
Enrollment | |||||||||||
 Informed consent | X |  |  |  |  |  |  |  |  |  |  |
 Sociodemographic profile | X |  |  |  |  |  |  |  |  |  |  |
 Medical history | X |  |  |  |  |  |  |  |  |  |  |
 Vital signs | X | X | X | X | X | X | X | X |  |  |  |
 Inclusion/exclusion criteria | X |  |  |  |  |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |  |  |  |  |
 Clinical laboratory tests | X |  |  |  |  |  | X |  |  |  |  |
Interventions | |||||||||||
 Acupuncture treatment |  |  | X | X | X | X | X |  |  |  |  |
 Trial medication prescription |  |  | X |  |  |  |  |  |  |  |  |
Assessments | |||||||||||
 Change of medical history |  |  | X | X | X | X | X | X | X | X | X |
 Safety assessment |  |  | X | X | X | X | X | X |  |  |  |
 Visual Analog Scale of pain |  |  | X |  |  |  | X | X |  |  |  |
 Foot and Ankle Outcome Score |  |  | X |  |  |  | X | X |  |  |  |
 Edema of ankle sprain |  |  | X |  |  |  | X | X |  |  |  |
 European Quality of Life 5-Dimension-5-Level Scale |  |  | X |  |  |  | X | X |  |  | X |
 Number of recurrent ankle injuries |  |  |  |  |  |  |  | X | X | X | X |