Can high-frequency spinal cord stimulation provide relief to patients with painful diabetic nerve disease?

This study evaluated the long-term impact of 10-kHz spinal cord stimulation (SCS) in patients with painful diabetic neuropathy (PDN; nerve disease) and refractory symptoms. The data supported the use of 10-kHz SCS for important, durable pain relief over 12 months in these patients.

Diabetic sensorimotor peripheral neuropathy (DSPN) is a common and serious complication due to diabetes. DSPN is associated with numbness, tingling, and neuropathic pain (pain due to abnormal nerve function). Some patients with DSPN can develop a burning or prickling sensation and shooting pain (painful diabetic neuropathy; PDN). Currently, there are no standardized, disease-modifying treatments for PDN. Therapy involves drugs for managing symptoms and behavioral changes. Recommended pain medications provide insufficient relief or side effects, leading to poor patient adherence.

SCS is a non-surgical pain treatment that delivers mild electrical pulses through a surgically implanted device to treat chronic back and leg pain. There is some evidence to suggest that SCS can provide pain relief for patients with PDN but the long-term impact has not been determined.

This study involved 216 patients with uncontrolled PDN after at least 12 months of treatment with medications. Patients were randomly assigned to two groups. 103 patients (group 1) received continued medical management (CMM) and 113 patients (group 2) received 10-kHz SCS, in addition to CMM. 77 patients in group 1 were crossed to 10-kHz SCS. Of these, 64 patients received permanent device implants (Nevro Corp., Redwood City, CA). 90 patients of group 2 received permanent device implants. Lower limb pain was assessed. Patients were followed for 12 months.

The average lower limb pain relief was 77.1%. The average lower limb pain relief for cross-over patients in group 1 was 70.3%. Over 12 months, 68% of patients originally assigned to SCS and 62% of patients after cross-over had improved sensory function.

The study showed improved pain relief after 12-months of high-frequency 10-kHz SCS for patients with PDN.

This study was funded by Nevro Corp., the manufacturer of the permanent device implants used. Both patients and investigators were aware of the treatments allocated, possibly influencing the study.