Christopher Gilligan, director of Brigham and Women’s Spine Service Line and associate chief medical officer of Brigham and Women’s Hospital (Boston, USA) talks to Spinal News International about restorative neurostimulation and how this technology can help treat those patients who suffer chronic low back pain.
What is restorative neurostimulation?
Restorative neurostimulation stimulates the multifidus muscle, which is the strongest stabilising muscle of the lumbar spine. The point here is that patients who have severe refractory chronic low back pain often have inhibition of that muscle. Consequently, they have a loss of neuromuscular control of their spine and a loss of functional spine stability. By using an implanted neurostimulator—that they turn on for 30 minutes twice a day—they are stimulating the multifidus, causing contractions, overcoming that inhibition, restoring their neuromuscular control and their functional spinal stability, and in that way, getting a reduction in pain and a reduction in disability.
What is the ReActiv8-B trial?
We studied a total of 204 patients at 26 centres around the world: Four in Australia, six in Europe and 16 in the USA. Our patients, on average, had 14 years of severe, refractory chronic low back pain. They had been to, on average, 31 physical therapy sessions and had all tried medications. In fact, more than a third (37%) of our patients started the study on opioid pain medications for their low back pain. None of our patients had prior spine surgery and all of our patients also had, on physical examination, signs of dysfunction in their multifidus muscle. We then implanted all of those patients and have followed them out to 36-months.
What were the key three-year results that you presented at the 2022 DWG-Kongress (7–9 December; Berlin, Germany)?
Key three year results that we presented include the fact that patients started on average with a pain score of 7.3. This is severe pain. However, after 36 months of stimulation, on average, their pain score was 2.3, which is mild pain. When it comes to disability, our patients on average started at 39 on the Oswestry Disability Index (ODI). That is right where moderate meets severe disability. After 36 months of stimulation, they were at 16 on average, and that is mild disability.
Finally, for health care related quality of life, after 36 months of stimulation, on average our patients had an EQ-5D score that was approximating a normal healthcare related quality of life for a similar population. When it comes to opioids, 49% of the patients on opioids voluntarily eliminated them and 22% voluntarily reduced them.
How significant are these results?
The main takeaway message from our research is that for patients with severe, refractory, mechanical, chronic low back pain, with signs of multifidus muscle dysfunction, if they haven’t had surgery and do not have an indication for surgery, we think that we have demonstrated an effective, safe therapy that may be an option for many of them. Our effectiveness results are really quite robust after 36 months, and we have seen excellent safety results as well.
The next steps in the research are that we are conducting a trial called the Restore trial. In that trial we are comparing this implanted restorative, or disease-modifying, stimulator to optimal medical management. So comparing a group of patients who are randomised either to get the neurostimulator or to get optimal medical management and compare the results between those two groups.
Chris Gilligan, MD, MBA, is associate chief medical officer and a pain medicine physician in the Division of Pain Medicine. In his administrative role, Gilligan is charged with leading hospital-wide initiatives in perioperative and periprocedural services that redesign the delivery of care to improve patient outcomes, clinician and patient satisfaction and operational effectiveness. Areas of focus include quality and safety, teamwork and professionalism, and operational performance.
He began his career at Brigham and Women’s Hospital in 1997 as a resident in General Surgery and Emergency Medicine. He then completed a fellowship in Pain Medicine at Massachusetts General Hospital and earned a Master’s in Business Administration from Harvard Business School. He also serves as the director of the Brigham and Women’s Spine Center. He remains clinically active, and continues to conduct clinical trials, and teach and mentor fellows, residents and students.
Gilligan, C., Volschenk, W., Russo, M. et al (2023) “Three-year durability of restorative neurostimulation effectiveness in patients with chronic low back pain and multifidus muscle dysfunction,” Neuromodulation: Technology at the Neural Interface, 26(1), pp. 98–108. Available at: https://doi.org/10.1016/j.neurom.2022.08.457.
Russo, M., Deckers, K., Eldabe, S. et al (2018) “Muscle Control and non-specific chronic low back pain,” Neuromodulation: Technology at the Neural Interface, 21(1), pp. 1–9. Available at: https://doi.org/10.1111/ner.12738.
Mitchell, B., Deckers, K., De Smedt, K. et al (2021) “Durability of the therapeutic effect of restorative neurostimulation for refractory chronic low back pain,” Neuromodulation: Technology at the Neural Interface, 24(6), pp. 1024–1032. Available at: https://doi.org/10.1111/ner.13477.
Deckers, K., De Smedt, K., Mitchell, B. et al (2018) “New therapy for refractory chronic mechanical low back pain—restorative neurostimulation to activate the lumbar multifidus: One year results of a prospective Multicenter Clinical Trial,” Neuromodulation: Technology at the Neural Interface, 21(1), pp. 48–55. Available at: https://doi.org/10.1111/ner.12741.
Gilligan, C., Volschenk, W., Russo, M. et al (2021) “An implantable restorative-neurostimulator for refractory mechanical chronic low back pain,” Pain, Publish Ahead of Print. Available at: https://doi.org/10.1097/j.pain.0000000000002258.
Gilligan, C., Volschenk, W., Russo, M. (2023) et al “Long-term outcomes of restorative neurostimulation in patients with refractory chronic low back pain secondary to multifidus dysfunction: Two-year results of the reactiv8-B pivotal trial,” Neuromodulation: Technology at the Neural Interface, 26(1), pp. 87–97. Available at: https://doi.org/10.1016/j.neurom.2021.10.011.