Painful diabetic neuropathy (PDN) is associated with chronic pain, sensory loss, and reduced quality of life; however, treatment options that improve both pain control and neurologic function remain limited. A multicenter randomized controlled trial presented at the ADA Scientific Sessions 2026 evaluated the efficacy of 10-kHz spinal cord stimulation (SCS) plus conventional medical management (CMM) compared with CMM alone in adults with PDN.

Eligible participants had lower-limb pain scores of at least 5 cm on a 10-cm visual analog scale and sensory impairment defined by a modified Toronto Neuropathic Clinical Score (mTNCS) greater than 5. Participants were randomized 1:1 to receive either 10-kHz SCS plus CMM or CMM alone. Key endpoints included pain responder rate, defined as at least 50% pain relief, and sensory improvement of at least 3 mTNCS points. Outcomes were assessed by an allocation-blinded evaluator. Participants were allowed to cross over to the alternate treatment arm after 6 months, with follow-up through 12 months. Among 91 randomized participants, 50 were assigned to CMM and 41 to 10-kHz SCS.

Findings

• At 6 months, both the pain responder endpoint (P<0.0001) and sensory responder endpoint (P=0.014) were met in the SCS group.
• None of the participants receiving SCS crossed over to CMM.
• Ninety-two percent of participants initially assigned to CMM crossed over to SCS treatment after 6 months.
• Improvements in pain and sensory function remained significant and sustained through 12 months, including among crossover participants.
• One device explantation (1.4%) occurred because of implant-site pain. No explants were reported because of lack of efficacy.

This multicenter randomized trial showed that 10-kHz spinal cord stimulation improved both pain and sensory function in adults with PDN. Benefits remained sustained through 12 months, supporting further evaluation of neuromodulation strategies in PDN management.