First-of-its kind study gives nurse relief from debilitating back pain

Back pain affects nearly everyone at one point or another, and many people need surgery to alleviate debilitating pain and numbness. The problem: Even after spine surgery, lasting nerve damage can mean that pain comes back.

Surgeons with M Health Fairview are testing a new procedure designed to combine spinal fusion surgery with neuromodulation, a long-term pain relief solution that could reduce the need for additional surgery or pain medication.

“Both of these therapies exist separately — spinal fusion and neuromodulation, which is often used when surgery alone doesn’t provide lasting pain relief,” said Rohan Lall, MD, a spine surgeon with M Health Fairview. “We want to establish through this study if it’s possible to do both spinal fusion and neuromodulation simultaneously to improve patient outcomes.”

Lall is working with Michael C. Park, MD, PhD, a neurosurgeon and University of Minnesota Medical School associate professor, to lead a proof-of-concept study at M Health Fairview in partnership with SynerFuse, a Minnesota-based medical company that worked with the University of Minnesota to develop and patent the integration of spinal fusion and neuromodulation into one procedure. Our surgeons performed the first-ever SynerFuse surgery in 2021, and we’ve since performed seven more, including a solo surgery by Lall.

Integrated surgery brings relief to nurse, mother of two

Sara Grieser struggled with back pain for over a decade before participating in the SynerFuse study last year. Her pain was so severe that she couldn’t sit on the bleachers to watch her children’s sports games, and she struggled to care for her patients as a registered nurse.

“I was grasping at straws to try and alleviate my symptoms,” said Grieser, who tried countless methods to manage her pain before getting connected to the study. “I finally said, ‘I can’t live like this anymore.’”

Grieser met with Lall at the M Health Fairview Neurosurgery Clinic – Princeton and asked if she would be a good candidate for SynerFuse. She became the fifth participant in the proof-of-concept study, undergoing surgery at M Health Fairview University of Minnesota Medical Center in July 2022.

Pain relief through electrical stimulation

Almost a year later, Grieser is virtually pain-free. Prior to surgery, she needed to have Tylenol on hand for constant flare-ups. Now, she can adjust the stimulation of her neuromodulation device and sit comfortably through her children’s sports games and performances.

Neuromodulation works to relieve pain by electrically stimulating the nerves. Surgeons place electrical leads on top of the nerve tissue. These leads send electrical signals to the nerve, which affect how that nerve perceives pain. During spinal fusion surgery, the nerves are exposed, and surgeons can easily place leads on top of the affected area.

These leads are connected to an external remote. After surgery, patients can control the electrical stimulation from their phone to manage any lasting or recurring pain symptoms.

“We perform spinal fusion to decompress and stabilize the nerves. The old school of thought is, if you remove the pressure, the nerves should recover. However, if they’ve been compressed too long, they can become permanently damaged,” said Park, who previously consulted for SynerFuse. “Once a person has had fusion surgery, it limits our ability to go back in and place leads on the affected nerves.”

Widening the study

Early data from the proof-of-concept study suggests the integrated procedure is safe and likely effective. The next step will be to extend the study to more patients, including those at other surgical centers. Researchers are also looking to expand the range of patients who are eligible for the study, which is currently only approved for those who need lumbar (lower) spine surgery and have not had a previous spinal fusion.

In performing the world-first surgery with M Health Fairview, Lall credits the collaboration between our neuromodulation experts and spine surgeons.

“We have excellent unification between our functional neurosurgeons who specialize in neuromodulation and our spine surgery team,” he said. “This collaboration has helped us enroll patients and provide this option to a range of people suffering from lower-back pain.”

The study has given Grieser hope.

“I missed a lot because I was in back pain for so many years,” she said. “Back pain is not something you can see, and it’s easy for others to discredit your pain. I enrolled in the trial because I wanted to help others, and it turned out that I got help, too.”