The following article is part of coverage from the American Diabetes Association’s 80th Scientific Sessions (ADA 2020). Because of concerns regarding the coronavirus disease 2019 (COVID-19) pandemic, all ADA 2020 sessions and presentations were transitioned to a virtual format. While live events will not proceed as planned, readers can click here to view more news related to research presented during the ADA 2020 virtual experience.
Spinal cord stimulation may be more effective than conventional medical management (CMM) alone for the treatment of painful diabetic neuropathy, according to study data presented during the American Diabetes Association’s 80th Scientific Sessions, held online from June 12 to 16, 2020.
The prospective, multicenter, randomized controlled SENZA-PDN trial (Comparison of 10 kHz [Spinal Cord Stimulation] Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain; ClinicalTrials.gov Identifier: NCT03228420) included 216 patients who had painful diabetic neuropathy symptoms for ≥12 months, lower limb pain intensity of ≥5 cm on a visual analog scale (0-10 cm), upper limb pain intensity of <3 cm, and hemoglobin A1c ≤10%. Participants were randomly assigned 1:1 to receive CMM plus neuromodulation in the form of 10 kHz spinal cord stimulation (n=113) or CMM alone (n=103).
The groups were well matched at baseline and were followed up for 3 months to examine changes in pain scores, neurologic function, and quality of life.
At 3 months, patients who received spinal cord stimulation plus CMM had significantly lower pain scores compared with those who received CMM alone (1.7 vs 6.5 cm, respectively). In addition, average score for the Diabetes Quality of Life measure improved in the neuromodulation group but remained essentially unchanged in the CMM alone group.
On physical examination at 3-month follow-up, 72% of patients who received CMM plus spinal cord stimulation showed improvement in monofilament and pinprick sensation. In contrast, sensation was improved in only 7% of patients who received CMM alone. Moreover, patient-reported distribution of numbness improved over 3 months with neuromodulation.
The intervention with spinal cord stimulation also improved sleep quality and walking ability. Patients who received spinal cord stimulation had a 17% increase in average distance walked during the 6-minute walk test and less trouble falling asleep and awakening because of neuropathic pain. These improvements were not seen with CMM alone.
The researchers reported 2 procedure-related infections in the group that received spinal cord stimulation (1.8%).
“Six million adults in the U.S. are living with painful diabetic neuropathy…and current treatments are ineffective for many,” noted the study authors. “SENZA-PDN is the largest [randomized controlled trial] to-date of [spinal cord stimulation] management of [painful diabetic neuropathy] and will inform the treatment continuum.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Petersen E, Stauss T, White JL, et al. Neuromodulation for treatment of painful diabetic neuropathy: a multicenter randomized controlled trial. Presented at: American Diabetes Association 80th Scientific Sessions; June 12-16, 2020. Abstract 31-LB.
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