Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial Multicenter Study
Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study.
Spinal cord stimulation is a recognized treatment of chronic neuropathic and vascular pain. Recent data suggest that the use of very high-frequency (HF) stimulation modes does produce analgesia without paresthesia. ⋯ This is the first randomized double-blind study on SCS. HFSCS was equivalent to sham for the primary outcome (improvement of PGIC) as well as for both the secondary outcomes (VAS and EQ-5D index). There was a highly statistically significant "period effect" (p = 0.006) with improved PGIC scores in the first study period regardless of the treatment. The same trend was seen for VAS and EQ-5D. It appears that the effect of HFSCS and sham is equal and only the order in the sequence, not the nature of the treatment, seems to dictate the effect.