A randomized, double-blind, crossover study of the use of transcutaneous spinal electroanalgesia in patients with pain from chronic critical limb ischemia

Transcutaneous spinal electroanalgesia (TSE) uses two electrodes placed over the skin of the dorsal spine to deliver pulses of short wavelength, high frequency, and relatively high voltage to the spinal cord without causing paresthesia. TSE has been used to treat pain and may improve limb blood flow. This randomized, double-blind, crossover study assessed the effect of TSE on microcirculation, pain, and activity in 8 patients (3 men, 5 women, median age 66.5 years, range 62-76 years) with chronic critical limb ischemia (CLI). After a one-week baseline period, patients used an active or inactive TSE machine for one hour daily for one week. Following a week of no stimulation, patients repeated the week of treatment with an identical matched machine. Daily use of TSE for one week did not improve microcirculatory perfusion (transcutaneous oxygenation), pain (verbal rating scale, McGill Pain Questionnaire), physical function (Functional Limitations Profile), mood (Beck Depression Inventory, Beck Anxiety Inventory), or sleep. There was no patient preference for the active TSE machines. This study showed that TSE administered daily for one week did not improve microcirculation, pain, or activity in patients with chronic CLI.