August 02, 2021
2 min read
August 02, 2021
2 min read
Gilmore reports he is a consultant for and a physician investigator with clinical research sponsored by SPR Therapeutics Inc.
Published results showed percutaneous peripheral nerve stimulation may provide clinically meaningful and statistically significant reductions in pain, disability and pain interference in patients with chronic low back pain.
Christopher A. Gilmore, MD, and colleagues collected data on 89 patients with chronic low back pain who were implanted with percutaneous open-coil peripheral nerve stimulation leads (MicroLead, SPR Therapeutics Inc.) that were connected to small wearable stimulators (Sprint PNS System, SPR Therapeutics Inc.) and targeted the lumbar medial branch nerves for up to 60 days, after which the leads were removed.
Reduction in pain intensity
After the 2-month peripheral nerve stimulation treatment, researchers followed patients long-term for 12 months, with the primary endpoint defined as the proportion of patients experiencing clinically significant reductions in chronic low back pain at the end of the 2-month treatment compared with baseline. Researchers also defined secondary endpoints as change in disability and pain interference, patient global impression of change, mean change in emotional state and mean change in health-related quality of life.
Christopher A. Gilmore
Among the 74 patients who completed peripheral nerve stimulation treatment, results showed 73% reported clinically meaningful reductions in back pain intensity at the end of the 2-month treatment. Researchers noted patients had an average reduction in average back pain intensity of 58%. Although prospective follow-up beyond 8 months is ongoing, researchers found clinically meaningful reductions in average back pain intensity among 57% of 51 participants who had already completed long-term follow-up visits through 14 months after the start of peripheral nerve stimulation.
Reductions in disability, pain interference
According to results, 73% of patients experienced clinically meaningful reductions in back pain-related disability, as well as pain interference at the end of the 2-month treatment. Researchers found 91% of patients reported improved quality of life at the end of the 2-month treatment, with 59% reporting a “much improved” quality of life compared with baseline. Patients also experienced improvement in all subscales of the RAND-36 measure of HRQoL, with the largest improvements found in the role limitations – physical health, pain and physical functioning subscales, results showed. Researchers noted a significant reduction in Beck Depression Inventory scores from baseline to the end of the 2-month treatment period.
Of the 20 participants who reported opioid analgesic consumption at baseline, results showed 63% experienced reduction in opioid usage and 21% experienced complete opioid cessation at the end of the 2-month percutaneous peripheral nerve stimulation treatment.
“The implications of this study should not be understated — temporary percutaneous peripheral nerve stimulation with Sprint provides a safe, effective and minimally invasive option for addressing treatment resistant chronic pain of the lumbar region,” Gilmore told Healio Orthopedics. “With nearly three-fourths of patients seeing clinically meaningful pain reduction along with important quality of life metrics, it is clear that the treatment is making a clear difference in the real-world lives of patients.”