Deep Brain Stimulation an Option for Chronic Low Back Pain?

Bari said the trial defined nonsurgical pain as low back pain that does not have a surgically addressable cause and has been deemed to be nonoperative by two surgeons. Investigators plan to enroll a total of 15 patients in the phase 1 study.

"We need more clinical trials of DBS that can test the most promising brain areas," said Bari. "This will require multisite clinical trials and cooperation between multiple centers and disciplines."

Generalizability Challenging?

Commenting on the research for Medscape Medical News, Michael Staudt, MD, MSc, University Hospitals Cleveland Medical Center, Ohio, who was not involved in the study, said one of the challenges is that the definition of nonsurgical back pain can vary widely between surgeons, payers, and interventionalists.

"So, when we say nonsurgical back pain, we're already putting [patients] into a category that's a little bit muddy," Staudt said.

He also noted that recent, large trials cleared by the US Food and Drug Administration are using spinal cord stimulation for nonsurgical back pain because it is low impact and offers another nonsurgical option for people who fail medical management.

"The step between spinal stimulation and deep brain stimulation is a big step," Staudt said. "It's not brain surgery to do a spinal cord stimulator. You won't find many people who are putting in deep brain stimulators, and the challenge with that is it's hard to say if you'd get enough patients in a large enough trial to show overall benefits and cost effectiveness."

"I do find it very interesting," Staudt added. "He's [Bari] published it and worked on it for a long time, but the applicability, the generalizability is challenging."

The study was funded by the National Institutes of Health. Bari reported serving as a consultant for Medtronic and Novartis and on the scientific advisory boards of Nervonik and Vonova. Co-investigator Nader Pouratian, MD, PhD, reported consulting for Abbott Laboratories and Sensoria Therapeutics. Staudt reported serving as a consultant for Abbott and a scientific advisor and consultant for Boston Scientific.