Sustained Treatment Effect of Spinal Cord Stimulation in Painful Diabetic Peripheral Neuropathy: 24-Month Follow-up of a Prospective Two-Center Randomized Controlled Trial

Spinal cord stimulation (SCS) has been demonstrated to serve as a successful second-line treatment modality for painful diabetic peripheral neuropathy (PDPN), as documented in two randomized clinical trials (RCTs) (1,2).Besides the fact that these two RCTs demonstrate a pain-relieving effect for a period of 6 months after the start of SCS treatment, only small observational studies suggest a long-term sustained effect in PDPN (3-5).In this article, we present the 24-month followup data of our recently published RCT in Diabetes Care (1).Thirty-six patients were enrolled in this study, and after randomization, 22 patients with PDPN in the lower limbs (15 male, mean age 57.1 years [SD 12.4], years of PDPN 6.0 [SD 5.1]) were assigned to the SCS group.A 2-week trial stimulation was performed to evaluate sufficient pain relief.After 6 months, 93% of patients in the control group crossed over to receive SCS. Treatment success of SCS was predefined in the protocol as $50% relief of pain intensity on a numeric rating scale (NRS) for 4 days during the daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 24 months.Additional outcome parameters were Figure 1-Mean pain scores at daytime and nighttime.