Spinal cord stimulation for painful diabetic neuropathy: how strong is the evidence?
What does the SENZA-PDN study show about spinal cord stimulation for painful diabetic neuropathy?
Painful diabetic neuropathy can cause persistent burning, tingling or electric-shock sensations, often affecting both feet. Medicines help some people, but others continue to experience severe pain despite treatment. Spinal cord stimulation (SCS) is one option being investigated and used in selected patients whose symptoms remain difficult to manage.
The SENZA-PDN randomised trial enrolled 216 people with painful diabetic neuropathy that had not responded adequately to conventional treatment. Participants initially received either conventional medical management alone or management combined with 10 kHz spinal cord stimulation, delivered through implanted electrodes.
A published follow-up report examined 142 participants who received an SCS system over 24 months. Their average reported pain reduction from baseline was 79.9%, and 90.1% achieved at least 50% pain relief. Improvements in sleep and quality of life were also reported. Five systems (3.2%) were removed because of infection.
Those numbers are encouraging, but they need careful interpretation. After six months, participants who were not improving sufficiently could cross over from conventional treatment to stimulation. Consequently, the two-year results describe outcomes among people who received SCS; they do not represent a straightforward two-year randomised comparison against continued medical treatment alone. Outcomes in a specialist trial may also differ from those in routine practice.
SCS involves an implant procedure, ongoing programming and follow-up. Potential complications include infection, lead problems and the need for further surgery. It does not replace good diabetes management, and it is not appropriate for everyone with neuropathic pain.
The evidence supports discussing SCS in carefully selected people with severe, treatment-resistant painful diabetic neuropathy. Decisions should consider the person's goals, other medical conditions, available alternatives and the balance of potential benefit and harm.
For patients: If standard treatments have not helped, ask whether a specialist pain service could assess your suitability. The large improvements reported in some studies are not a guarantee of individual benefit.
Original research
- SENZA-PDN, 24-month follow-up, *Diabetes Research and Clinical Practice* (2023): https://pubmed.ncbi.nlm.nih.gov/37536514/