Table 1 Human studies related to ESWT for peripheral arterial disease

Ciccone MM, Notarnicola A [23]

Randomised control trial

N = 22, cases = 12, controls =10

4 sessions at 1 weekly intervals, 2000 impulses, 0.03 mJ/mm². Aimed at stenotic lesion

Increased pain-free walking distance and reduction in pain severity. Reduction in degree of arterial stenosis. Reduced Fontaine staging

Small sample size, short-term follow-up

Tara S, Miyamoto M [24]

Prospective non-randomised pilot study

N = 10

6 sessions (3 times per week for 2 weeks). 6 spots per session (300 impulses/spot) 0.11–0.12 cmJ/mm²

No adverse events.

Improved transcutaneous oxygen tension (TcPO₂) in both calf and dorsum of foot. Scintography demonstrated improved perfusion in dorsum of foot only

Small sample size, non-randomised, short-term follow-up

Belcaro G, Cesarone MR [25]

Prospective non- randomised

N = 32

6 sessions (3 times per week for 2 weeks) 1000 impulses per session, 0.08–0.43 mJ/mm²

Improved pain-free walking distance, analogue scale for pain, laser Doppler skin perfusion, partial pressure of oxygen and decreased partial pressure of carbon dioxide. Reduced ORACLE score

Small sample size, non-randomised short-term follow-up

Serizawa F, Ito K [26]

Prospective non-randomised

N = 12

9 sessions (3 times per week for 3 weeks) 40 spots per session with 200 impulses/spot 0.1 mJ/mm²

Improved maximum walking distance, walking impairment questionnaire scores and shorter recovery time

Small sample size, non-randomised, short-term follow-up

Serizawa F, Ito K [26]

Prospective non-randomised

N = 6

6 sessions (3 times in first week (days 1, 3 and 5) and 3 sessions in week 5 (days 29, 31, 33) 40 spots per session with 200 impulses/spot 0.1 mJ/mm²

The maximum walking distance was significantly increased at 4 weeks and 8 weeks follow-up

Small sample size, non-randomised, short-term follow-up