Petersen EA, et al. Mayo Clin Proc Innov Qual Outcomes. 2022;doi:10.1016/j.mayocpiqo.2022.05.003.

Petersen EA, et al. Mayo Clin Proc Innov Qual Outcomes. 2022;doi:10.1016/j.mayocpiqo.2022.05.003.

Treatment combining an implanted 10 kHz spinal cord stimulator and conventional care yielded better quality of life for adults with painful diabetic neuropathy, according to study findings.

As Healio previously reported, in a prospective randomized controlled trial, treatment with an implanted 10 kHz spinal cord stimulator (Nevro) and continued conventional medical management was associated with more pain relief, fewer sleep disturbances and neurologic benefits compared with conventional management alone.

In new findings published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes, spinal cord stimulation improved several quality of life metrics for adults randomly assigned to spinal cord stimulation and conventional care at baseline as well as for those in the control group who crossed over to spinal cord stimulation and conventional care at 6 months.

“The study results included significantly less pain interference with sleep, mood and daily activities for patients who received 10 kHz spinal cord stimulation,” Erika A. Petersen, MD, professor of neurosurgery at the University of Arkansas for Medical Sciences in Little Rock, told Healio. “Importantly, at 12 months, participants experienced a mean improvement in the EuroQoL 5-Dimension questionnaire index score of 0.136, which is 2.7 to 4.5 times the minimum improvement that is considered clinically meaningful for diabetes patients. In addition, greater than 70% of clinicians assessed the participants to have overall improvement with 10 kHz spinal cord stimulation, and greater than 70% of participants viewed themselves to have overall improvement.”

Petersen and colleagues conducted a randomized controlled trial enrolling 216 adults with painful diabetic neuropathy symptoms for at least 12 months at 18 centers in the U.S. (mean age, 60.8 years; 37% women). Participants were randomly assigned to 10 kHz spinal cord stimulation plus conventional medical management (n = 113) or conventional medical management alone without spinal cord stimulation (n = 103) for 12 months. At 6 months, the conventional management group had the option of crossing over to spinal cord stimulation if they had less than 50% pain relief from baseline and were dissatisfied with treatment. Health-related quality of life was assessed with the EuroQol 5-Dimension 5-Level questionnaire and the Diabetes Quality of Life questionnaire. The Pain and Sleep Questionnaire three-item index was used to evaluate sleep quality at baseline. Clinicians evaluated participants’ mental well-being through the Global Assessment of Functioning and the Clinician Global Impression of Change. Participants completed the Patient Global Impression of Change and satisfaction questionnaire.

There were 104 participants in the spinal cord stimulation group who completed the 12-month trial. In the conventional medical management group, 95 completed the 6-month follow-up and 77 crossed over to spinal cord stimulation at that time.

The spinal cord stimulation participants had an overall quality of life score of 58.7 of 100 at baseline. The mean score rose by 14.7 points at 6 months and 17 points at 12 months. The mean index value of the questionnaire was 0.644 of 1 at baseline, which improved by 0.124 points at 6 months and by 0.136 at 12 months. Participants who crossed over to spinal cord stimulation at 6 months had a mean quality of life score of 58.1 at baseline. The score rose by 17.3 points at 12 months. The mean index value was 0.63 at baseline and rose by 0.13 points at 12 months.

Mean Diabetes Quality of Life score was 2.5 of 5 points for the treatment group at baseline. Participants reported improvements in all subscales of the questionnaire at 6 months, which were sustained through 12 months. Similarly, the crossover group had a baseline score of 2.6 of 5 and had improvements across all subscales at 12 months.

Both the treatment and crossover groups had poor sleep quality at baseline. After spinal cord stimulation, the treatment group had a 62.4% improvement with pain interference with sleep and the crossover group at a 60.6% improvement at 12 months.

According to participating clinicians, the treatment group had a mean baseline score of 63.1 of 100 in the Global Assessment of Functioning questionnaire. The score rose by 18.4 points at 6 months and 20.7 points at 12 months. The crossover group had a mean baseline score of 62.1 points. The score decreased by 4.9 points at 6 months with continued medical management only. After crossing over to spinal cord stimulation, the score increased 16.9 points at 12 months.

Among all participants receiving spinal cord stimulation, 46% were satisfied with treatment at 12 months and 60% were very satisfied. Clinicians and participants both stated most were either “better” or “a great deal better” in the Global Impression of Change questionnaire.

“First-line therapies for painful diabetic neuropathy include several pharmaceuticals,” Petersen said. “The study results show that 10 kHz spinal cord stimulation provides large, clinically meaningful reductions in pain as well as large improvements in sleep and quality of life. Clinically, the implications are substantial as doctors now have a new treatment option to offer their patients, and one that can provide real benefits to patients’ lives.”

Erika A. Petersen, MD, can be reached at eapetersen@uams.edu.

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