| Methods |
Study design: states random, method unknown, not blinded
Losses to follow up: no losses to follow up |
| Participants |
Country: Italy
Number of participants: 12
Sex: male and female
Age: mean age 71 years
Inclusion criteria: CLI (Fontaine stage IV), plus multi‐level distal lesions on angiogram
Exclusion criteria: individuals with diabetes and compromising medical conditions |
| Interventions |
Treatment: distal surgical bypass, ideally using a vein (prosthetic graft was used if this was not possible)
Control: spinal cord stimulation, with the electrode introduced under local anaesthesia; treatment was generally continued for a period of 7 to 14 days
Duration: 12 months |
| Outcomes |
Amputation rate
Subjective improvement: good/fair (complete or evident pain relief and trophic lesion healing); or poor |
| Notes |
No source of funding/sponsorship was reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No description of randomisation method. Allocation by randomisation only mentioned in 1 sentence in abstract but not in main text. |
| Allocation concealment (selection bias) |
Unclear risk |
See above. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
See below. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
No blinding performed, but lack of blinding unlikely to influence outcomes. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
No blinding described, but the review authors judged that the outcome and the outcome measurement were not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Insufficient reporting of attrition/exclusions to permit judgement. |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement. |
| Other bias |
Low risk |
No other source of bias was identified. |
