ABSTRACT
The purpose of this study was to assess changes in pain and physical activity after replacing a traditional spinal cord stimulation (SCS) implantable pulse generator with a next generation SCS in patients for whom traditional SCS was no longer providing adequate relief of low back and/or leg pain. Subjects (n = 19) who reported that they were no longer receiving adequate relief from traditional SCS were implanted with a next generation SCS. Eighteen additional patients who were receiving relief from traditional SCS were also followed as a control. Both groups (next generation, traditional) were assessed for low-back and limb pain (visual analog scale) and daily physical activity (wearable accelerometer) at baseline and three, six, nine and 12 months following the SCS implant. Relative to baseline, next generation SCS subjects exhibited reductions (p ≤ 0.05 for all) in low-back pain (average reduction of 22%) at every time point, in leg pain (average reduction of 23%) at every time point except six months and increased physical activity (average increase of 57%) at three, six and nine months. As expected, there were no changes in pain or physical activity in the traditional SCS subjects (p ≥ 0.1). In conclusion, pain decreased, and physical activity increased in patients receiving a next generation SCS. Physical activity may serve as an objectively measured marker of pain.
ABSTRACT
BACKGROUND: The aim of this study was to determine whether spinal cord stimulation (SCS) using 3D neural targeting provided sustained overall and low back pain relief in a broad routine clinical practice population. STUDY DESIGN AND METHODS: This was a multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort. After IPG implantation, programming was done using a patient-specific, model-based algorithm to adjust for lead position (3D neural targeting) or previous generation software (traditional). Demographics, medical histories, SCS parameters, pain locations, pain intensities, disabilities, and safety data were collected for all patients. RESULTS: A total of 213 patients using 3D neural targeting were included, with a trial-to-implant ratio of 86%. Patients used seven different lead configurations, with 62% receiving 24 to 32 contacts, and a broad range of stimulation parameters utilizing a mean of 14.3 (±6.1) contacts. At 24 months postimplant, pain intensity decreased significantly from baseline (ΔNRS = 4.2, N = 169, P < 0.0001) and even more in in the severe pain subgroup (ΔNRS = 5.3, N = 91, P < 0.0001). Axial low back pain also decreased significantly from baseline to 24 months (ΔNRS = 4.1, N = 70, P < 0.0001, on the overall cohort and ΔNRS = 5.6, N = 38, on the severe subgroup). Matched cohort comparison with 213 patients treated with traditional SCS at the same centers showed overall pain responder rates of 51% (traditional SCS) and 74% (neural targeting SCS) and axial low back pain responder rates of 41% and 71% in the traditional SCS and neural targeting SCS cohorts, respectively. Lastly, complications occurred in a total of 33 of the 213 patients, with a 1.6% lead replacement rate and a 1.6% explant rate. CONCLUSIONS: Our results suggest that 3D neural targeting SCS and its associated hardware flexibility provide effective treatment for both chronic leg and chronic axial low back pain that is significantly superior to traditional SCS.
