Study period | |||||
---|---|---|---|---|---|
Enrollment/allocation | Post-allocation | Follow-up | Close-out | ||
Timepoint | D0 (= BL) | D0 (= BL) | W1, W2, W3 | W4 | W12 |
Enrollment | |||||
Clinical evaluation | X | ||||
Eligibility screen | X | ||||
Allocation | X | ||||
Interventions | |||||
rESWT | X | X | |||
C + E | X | X | |||
Assessments | |||||
A, G, BH, BW, Du, ES, MS, Co | X | ||||
Safety | X | X | X | X | |
PSEQ score | X | X | X | X | |
NRS score | X | X | X | X | |
OLBPDQ score | X | X | X | X | |
PHQ-9 score | X | X | X | X |