Spinal cord stimulation may be a viable treatment option for relieving pain and protecting sensation among patients with painful diabetic neuropathy. These findings from SENZA-PDN (ClinicalTrials.gov Identifier: NCT03228420), a prospective, multicenter, randomized controlled trial, will be presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting held April 17 to 22, 2021.
For this study, researchers recruited patients (N=216) with diabetes who were diagnosed with neuropathy at least 12 months previously, were refractory to medications, had lower limb pain intensity of 5 cm or more (0-to-10-point visual analog scale), little upper limb pain (<3 cm), did not use more than 120 mg morphine equivalents per day, and had controlled HbA1C (≤10%).
Study participants were randomly assigned in a 1:1 ratio to receive 10 kHz spinal cord stimulation with conventional therapy (n=113) or usual therapy alone (n=103). At 6 months, patients received a neurologic examination and were assessed for pain and quality of life. At baseline, the patient groups were well-balanced for characteristics.
The average pain intensity was reported to be 7.6 and 7.0 cm at baseline among the participants in the treatment and control cohorts, respectively. At 6 months, the treatment group participants reported pain to be 1.7 cm, 85% had at least 50% pain relief, and 2.3% had worsening pain (P <.001); in contrast, the control group participants reported pain as 6.9 cm, 6.3% had at least 50% pain relief, and 52% had worsening pain symptoms.
At the follow-up neurologic examination, 65.9% of the treatment group participants and 8.5% of the control cohort participants exhibited improvements (P <.001). Two patients who had been randomly assigned to the treatment group required device explants due to infection.
This study was limited by its low sample size and short study duration. These findings should be validated among a larger population of patients with a longer follow-up, the study authors noted.
Study researchers concluded that their data indicated 10 kHz spinal cord stimulation may reduce pain intensity and increase protective sensation among patients with painful diabetic neuropathy.
Petersen E, Stauss T, Scowcroft J, et al. Sustained benefits for 10 kHz spinal cord stimulation treatment of painful diabetic neuropathy – six month results from a multicenter randomized controlled trial. JAMA Neurol. Published online April 5, 2021. doi:10.1001/jamaneurol.2021.0538
This article originally appeared on Neurology Advisor