Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Enrolment | Rehabilitation | Allocation | Post-allocation | Close out | ||||||
Timepoint in months | − 3¼ to − 6¼ | − 3 to − 6 | − 1½ to − 4½ | 0 to − 3 | 0* | 0 | ¼ | 3 | 6 | 12 |
Enrolment | ||||||||||
Patient information and consent | x | |||||||||
Informed consent collection | x | |||||||||
Validation of inclusion and exclusion criteria | x | |||||||||
Randomization | x | |||||||||
Interventions | ||||||||||
Organize rehabilitation | x | |||||||||
Rehabilitation checkpoint | x | x | x | x | x | |||||
Needling (with PRP or Saline) | x | |||||||||
Assessment | ||||||||||
Clinical evaluation | x | x | ||||||||
Elbow echography | x | x | x | x | x | |||||
Demographics | x | |||||||||
Rehabilitation efficacy assessment | x | x | ||||||||
Primary outcome assessment | x | |||||||||
Clinical outcome assessment | x | x | x | x | x | x | x | |||
Concomitant therapy, surgery | x | x | x | x | x | x | x |