A Prospective, Open-Label, Pilot Study to Assess the Effect of Spinal Cord Stimulation on Quality of Sleep and Activity Levels in patients with Chronic Low Back pain with or without Leg Pain

Spinal cord stimulation (SCS) is a minimally invasive procedure used for the treatment of persistent, refractory and neuropathic pain. Conventional SCS systems require regular manual adjustments of the level of electrical stimulation after initial programming. These adjustments are necessary because the level of the spinal cord stimulation is dependent on the distance between the spinal cord and the implanted electrodes, which changes with patient’s daily activity (e.g., standing, lying down, seating, etc.). When a patient changes body position, the movement of the spinal cord relative to the implanted lead may result in uncomfortable or inconsistent stimulation. This may lead to suboptimal pain control and significantly reduce the effectiveness of the SCS therapy, which may impact heavily on patient’s quality of life. For instance, one of the most important daily activities – sleep, may be significantly affected by the inconsistent stimulation. This may compromise effective treatment and lead to increase in the levels of dissatisfaction and pain. The RestoreSENSOR (Medtronic Inc, USA) is the first in its class implantable pulse generator for spinal cord stimulation that automatically changes stimulation settings in response to position changes and provides objective patient activity data. It achieves this thanks to the inbuilt acceleration sensor that enables continuous motion sensing. The Medtronic RestoreSENSOR neurostimulator also records and stores the frequency of patient’s posture and activity changes. These objective data can be used by the clinician to understand whether the patient’s individual stimulation requirements are changing over time. If the SCS therapy with RestoreSENSOR improves patients’ quality of sleep and activity levels in this study, this will demonstrate superior effectiveness of position-adaptive stimulation technology in providing pain relief and convenience to patients suffering from chronic pain. Improvement in quality of sleep and daily activity levels will serve as an indicator of efficacy of the treatment.