A clinical trial showed that SCS provided pain relief in patients with PDPN….
New treatments are needed for painful diabetic peripheral neuropathy (PDPN). The current pharmacological treatment options available for this common complication of diabetes mellitus are usually only partially effective or their accompanied side effects are unbearable. In the past, small observational studies have suggested that positive effects may be seen with spinal cord stimulation (SCS), so a multicenter clinical trial was performed to further investigate this theory.
Researchers conducted a prospective, two-center, randomized, controlled trial consisting of 36 PDPN patients suffering with severe lower limb pain that were not responding to conventional therapy. These patients were randomly assigned to either SCS in addition to the best medical treatment (BMT), referred to as the SCS group, or BMT alone, referred to as the BMT group. There were a total of 22 patients in the SCS group and 14 patients in the BMT group. The SCS system was only implanted if trial stimulation worked successfully. The treatment was considered successful if the patient experienced ≥50% pain relief during daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 6 months.
Trial stimulation worked successfully in 77% of the SCS patients. Additionally, 59% of the SCS patients and 7% of the BMT patients experienced treatment success (p <0.01). In the SCS group, pain relief during daytime and during nighttime was reported by 41 and 36% of patients (p <0.05), and pain and sleep were "(very) much improved" in 55 and 36% of patients (p < 0.001); however, one patient died due to a subdural hematoma. In the BMT group, on the other hand, pain relief during daytime and during nighttime was reported by 0 and 7% of patients (p <0.05), and no changes were seen in pain and sleep (p <0.05).
Over a 6-month period, treatment success was established in 59% of patients with PDPN who were treated with SCS. This treatment, however, can be risky.
- When treated with SCS in combination with BMT, 59% patients with PDPN experienced treatment success, while only 7% of patients treated with BMT alone experienced treatment success.
- However, one patient in the SCS group died due to a subdural hematoma.
- Although there are risks, SCS proved to be an effective pharmacological treatment option.
Published online on Sept 11, 2014 in Diabetes Care.