Table 4 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram of events timeline
Study period | |||||||
|---|---|---|---|---|---|---|---|
Enrolment and screening | Allocation | Post randomisation | Exit | ||||
Timepoint | Treatment period | 4/52 F/U | 8/52 F/U | 12/52 F/U | |||
Enrolment: | |||||||
Eligibility screen | X | ||||||
Demographics | X | ||||||
Past medical history | X | ||||||
Provision of Patient Information Sheet | X | ||||||
Informed consent | X | ||||||
Randomisation/allocation | X | ||||||
Interventions: | |||||||
Active shockwave treatment (Group A) | 9 sessions (3 × per week for 3 weeks) | ||||||
Sham treatment (Group B) | 9 sessions (3 × per week for 3 weeks) | ||||||
Assessments: | |||||||
Ankle-brachial pressure index | X | X | X | X | |||
Claudication distance | X | X | X | X | |||
Maximum walking distance | X | X | X | X | |||
SF-36 questionnaire | X | X | X | X | |||
EQ-5D questionnaire | X | X | X | X | |||
Patient tolerability VAS | Recorded after each treatment | ||||||
Adverse events (bruising, bleeding, etc.) | Recorded after each treatment | X | X | X | |||