Spinal Cord Stimulator Improves Pain in Patients with Failed Back Surgery Syndrome: A Prospective Study with up to 2 Years of Follow-up

Objectives Chronic pain as a result of failed back surgery is a difficult to treat condition. Despite advances in surgical techniques and medication strategies, a long-term reduction in pain after failed back surgery may be difficult to achieve, leading to a decrease in quality of life and to permanent disability.

Spinal cord stimulation (SCS) implants have been designed to mask pain signals before they reach the brain, potentially helping patients in which spine surgery has failed to improve their pain.

In the current study, we prospectively followed 82 patients who received a spinal cord stimulator (NEVRO HF10) for chronic pain associated with failed back surgery syndrome. We aimed to determine whether the device would provide significant short- and long-term pain relief.

Methods This was a prospective series of patients with chronic pain due to failed back surgery syndrome who were operated on by a single surgeon to implant a spinal cord stimulation device. Patients were surveyed pre-implantation and at 6, 12 and 24 months after implantation of the SCS. Using a Visual Analog Scale (VAS), we aimed to quantify pain pre- and post-implantation in the lower back (LB) and both legs (LL & RL)individually. In addition, patients were asked about their pre-implantation functional status, as well as their perception of pain relief. Statistical analyses were conducted using R. Generalized linear models of VAS score as a function of time post-implantation were used to estimate the effect of the SCS on pain. A P-value <  0.05 was deemed to be statistically significant for all analyses.

Results and Conclusion 82 patients (28 men and 54 women) received SCS implantation. The mean VAS score pre-implantation was: Lower Back = 8.0, Left Leg = 7.8, Right Leg = 7.6. We found a significant reduction in pain 6 months post-implantation: LB = 3.7, LL = 3.3, RL = 3.3 (P <  0.05). The reduction in pain persisted for up to two years after implantation of the SCS.

The Nevro HF10 spinal cord stimulator demonstrated to significantly improve pain in patients with failed back surgery syndrome at short- and long-term intervals. With a safe, minimally invasive implantation technique, the spinal cord stimulator may be an additional tool in the management of hard-to-treat chronic pain patients.

Additional analyses are being conducted to better understand the effect of the stimulator in reducing pain depending on the affected region and on the baseline disability status of the patient.

Stichwörter spinal cord stimulation; nevro; chronic pain; failed back surgery syndrome;

Publication History

Article published online:
15 October 2020