In my practice, patients undergo a "stimulation trial." If the trial is successful, and the patient meets all indications, then surgical implantation of the spine cord stimulator is performed.
About the Clinical Trial
The multicenter randomized clinical trial involved 36 patients with moderate-to-severe diabetic peripheral neuropathy in their lower limbs that failed to respond to conventional treatments. All patients had a pain intensity of ≥5 on a numeric rating scale and were given best medical treatment (BMT) before enrollment in the trial. All other potential causes of pain were ruled out, and psychological assessment was used if necessary.
The patients were randomized to SCS plus BMT (n=22) or to continue BMT alone (n=14). SCS implantation was performed only after a trial stimulation showed treatment success, which was defined as ≥50% pain relief during the day or night or score of ≥6 (ie, “much improved” or “very much improved”) on the Patient Global Impression of Change (PGIC) scale at 6 months. Best medical treatment was defined by international guidelines, and an evidence-based treatment algorithm developed by Jensen et al.
Treatment Success Found in Nearly 60% of Patients
Approximately three-fourths of the patients (77%) responded to the SCS trial. Treatment success at 6 months was found in 59% of the SCS group compared with 7% of BMT group (P<0.01). Pain relief of ≥50% during the daytime or at night was found in a significantly greater proportion of the SCS group (41% and 36%, respectively) than in the BMT group (0 and 7%; P<0.05). On the PGIC scale, pain and sleep scores of ≥6 were found in 55% and 36% of the SCS group compared with none of the patients who received BMT alone (P<0.001 and P<0.05, respectively).
Adverse Events Reported
Two serious adverse events related to use of SCS were reported: one involving a serious infection at 6 weeks postimplantation that resolved following antibiotic treatment, and one involving a dural puncture during implantation of the stimulation lead that resulted in a subdural hematoma and death. Only one other report of a subdural hematoma after SCS implant has been reported in the literature, suggesting that this is “an extremely rare complication,” the authors noted.
November 15, 2014
Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016-3024.