Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study.
OBJECTIVE
This study was designed to test the hypothesis that spinal cord stimulation (SCS) improves limb salvage in patients with inoperable severe leg ischaemia.


METHODS
Prospective randomised controlled study with 18 months follow-up.


METHODS
Vascular surgical units in two university hospitals.


METHODS
Atherosclerotic (n = 41) and diabetic (n = 10) patients having chronic leg ischaemia with rest pain and/or ischaemic ulcerations due to technically inoperable arterial occlusions.


METHODS
Limb salvage and amount of tissue loss within 18 months, pain relief.


RESULTS
Twenty-five patients were randomized to SCS and 26 to analgesic (control) treatment. Macrocirculatory parameters were not different in the two groups during follow-up. Long-term pain relief was observed only in the SCS group. At 18 months, limb salvage rates in the SCS and control groups were 62% and 45% (N.S.). Tissue loss was less (p = 0.05) in the SCS group. A subgroup analysis of patients without arterial hypertension showed a significantly lower amputation rate in the SCS vs the control group.


CONCLUSIONS
SCS provided long-term pain relief but limb salvage at 18 months was not significantly improved by SCS in this rather small study. The results suggest that SCS may reduce amputation levels in patients with severe inoperable leg ischaemia and be most effective in patients without arterial hypertension.
Jivegård
L E
LE
Department of Surgery, Sahlgrenska, Sweden.
Augustinsson
L E
LE
Holm
J
J
Risberg
B
B
Ortenwall
P
P
D000368:Aged; D001794:Blood Pressure; D002908:Chronic Disease; D004599:Electric Stimulation Therapy; D005260:Female; D006439:Hemodynamics; D006801:Humans; D007511:Ischemia / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D007866:Leg / Q000098:blood supply* / Q000601:surgery; D008297:Male; D059408:Pain Management; D010147:Pain Measurement; D011446:Prospective Studies; D012881:Skin Temperature; D013116:Spinal Cord