Real-world evidence on spinal cord neuromodulation and pain: Long-term effectiveness analysis in a single-center cohort.

INTRODUCTION

Chronic pain inflicts damage in multiple spheres of patient's life and remains a challenge for health care providers. Real-world evidence derived from outcome registries represents a key aspect of the ongoing systematic assessment and future development of neurostimulation devices.

RESEARCH QUESTION

The objective of the present study was to assess the long-term effectiveness of neurostimulation as a treatment for spinal chronic pain.

MATERIAL AND METHODS

The patients analyzed in the present study represent a singlecenter cohort of 52 individuals. Primary outcome measures included numeric pain rating scale, Beck depression index II and Oswestry disability index variation from baseline to 36-month visits. Secondary outcomes included its evaluation at 6-month, 12-month and 24-month visits.

RESULTS

A significant improvement in targeted pain, depression and disability values were observed at 36-month follow-up (P ​< ​0.001, P ​= ​0.009 and P ​< ​0.001 respectively). Those results were consistent in the leg and back pain subgroup but not in the neck, chest and arm pain subgroup. The decrease in pain, depression and disability values happened progressively through time, with the exception of the 12-month visit, where a mild stagnation was observed.

DISCUSSION AND CONCLUSION

Our results suggest that spinal cord stimulation is an effective long-term treatment for spinal chronic pain in real-world conditions when applied to a variety of patients and conditions usually seen in routine practice. Nevertheless, some fluctuations may occur during treatment so prolonged follow-up periods should be considered before rendering an unsuccessful therapy diagnosis.