Novel Treatment Modality May Ease Painful Diabetic Neuropathy

High-frequency spinal cord stimulation may offer new hope for people suffering from painful peripheral diabetic neuropathy.

The Senza 10kHz Spinal Cord Stimulation (Nevro Corporation) was approved by the U.S. Food and Drug Administration in 2015 for the treatment of chronic intractable pain of the back and lower extremities. Now, Cleveland Clinic is participating in a pivotal randomized clinical trial to see whether the device can alleviate severe pain associated with diabetic peripheral neuropathy, an often-debilitating condition that affects up to 40 percent of the 30 million Americans with diabetes.

“Peripheral diabetic neuropathy results in significant disability, diminished quality of life, and increased health care costs. The efficacy of current medical management is very limited,” says Cleveland Clinic pain management specialist Jijun Xu, MD, PhD.

Indeed, among the drugs currently approved by the FDA to treat painful diabetic neuropathy, duloxetine (Cymbalta®, Eli Lilly) can cause nausea, insomnia, and headache, while pregabalin (Lyrica®, Pfizer) is associated with drowsiness and confusion and tapentadol (Nucynta®, Depomed) with nausea and dizziness.

“We’ve been looking for a therapy that is effective and doesn’t cause a lot of side effects,” Dr. Xu says.

High-frequency (10kHz) therapy involves application of short-duration (30 μs), low amplitude (1-5 mA) pulses to the spinal epidural space. Unlike traditional lower-frequency spinal cord stimulation devices, the high-frequency version does not produce paresthesias and therefore has proven more tolerable for patients when used as treatment for back and leg pain.

The new prospective, open-label randomized trial will compare the “HF10” therapy plus medical management to medical management alone in 360 patients with chronic, intractable, neuropathic limb pain due to diabetic neuropathy. Safety, clinical effectiveness, cost-effectiveness, and health-related quality of life will be assessed over 24 months.

Cleveland Clinic aims to enroll 40 of the study subjects, who will be managed by a multidisciplinary team including endocrinologists, neurologists, and pain specialists.

After 6 months, patients from either group will have the opportunity to switch treatment arms if they achieve less than 50 percent pain reduction as measured by visual analog scales, or if complications arise from the device. “The rate of crossover will demonstrate treatment efficacy as well,” Dr. Xu notes.

He hopes the study will lead to a paradigm shift in treating this challenging patient population. “I think this should be an interesting study and we should be able to find out whether this is really effective for patients suffering from painful peripheral diabetic neuropathy. If so, then I think high-frequency spinal cord stimulation should be considered as part of the treatment algorithm early in the course of the condition because it could improve patients’ quality of life and function.”

Results are expected in 2020.

To refer patients for the study, go to clevelandclinic.org/paintrials.