Abstract

Objective: The aim of this survey was to collect user (patient and health care professional) satisfaction, therapy outcomes and device settings from patients who utilize a single spinal cord stimulation model for treatment of chronic pain in day-to-day clinical practice. Methods: The design was a clinical survey. The survey population were patients with chronic back and leg pain receiving spinal cord stimulation therapy, and the health care professionals who treat the patients and program the implantable neurostimulator. Patient data were collected once and at a time when spinal cord stimulation provided stable pain relief. Data was presented in aggregate form. Near 50 data-items were captured per patient, including demographics (e.g., age, gender, prior surgeries), technical data (e.g., implant details, stimulation parameters), patient reported outcomes (e.g., pain change, goal achievement, work) and satisfaction and health care professional satisfaction (e.g., satisfaction with neurostimulator size). Descriptive statistics were used to summarize the data. Continuous variables are summarized by computing mean and standard deviation. Results: Clinical staff from nine European sites independently collected data from 124 patients. Patients were on average 54.3 (±11.2) years old and had chronic pain for 9.9 (±6.0) years. The average time since spinal cord stimulation onset was 2.6 years. The indication for spinal cord stimulation was for overall pain (68.5%, 85/124), leg pain (22.6%, 28/124) and back pain (8.9%, 11/124). On average, patients reported an improvement in pain of 70.3% (± 17.1%) and pain medication was reduced for 82.3% (102/124) of patients. Thirtytwo patients (25.8%) returned to work of whom 16 (12.9%) returned to full time work. Functional goals measured on a VAS scale (0-100), were predefined by 110 patients, mostly for pain/medication reduction, improved quality of life, and mobility. On average, there was an improvement in the predefined goal, of 73.3% (±17.0%). Conclusions: The clinical survey provided an overview of the use of spinal cord stimulation for a specific device and indication in a day-to-day clinical setting.

Keywords

neurostimulator, spinal cord stimulation, chronic back and leg pain