Prospective outcome evaluation of spinal cord stimulation in patients with intractable leg pain

Study Design. The results of spinal cord stimulation were prospectively evaluated using both subjective patient self-report measures and objective physical functional testing. Objectives. The purpose of this study was to evaluate prospectively the effects of spinal cord stimulation implantation, performed with the patient awake and providing feedback, in patients with primary reports of intractable leg pain. Summary of Background Data. Spinal cord stimulation has been used for treating chronic pain of many types. However, even among those with intractable lower extremity pain, the outcome results have shown great variability. Methods. The surgical procedure was performed with the patient awake and providing feedback to ensure optimal pain relief from the lead placement. The study group comprised 40 patients, ranging in age from 28 to 86 years. The average symptom duration was 65.4 months, and the average number of prior lumbar spine surgeries was 2.3 (range, 1 to 8). The primary data collection periods were preoperative, 6 weeks after, and 12 and 24 months after surgery. Results. Statistically significant improvement in isometric lower extremity function was demonstrated 6 weeks after the spinal cord stimulation implantation. In the more painful leg, the performance increased from 457.5 ft-lb . sec to 629.8 ft-lb . sec (P < 0.01). The performance remained significantly improved at the 12- and 24-month follow-ups. Significant improvement was demonstrated on the physical scale of the sickness Impact profile at 6 weeks. At 24 months, all three scales (physical, psychological, and other) as well as the total score were significantly improved. Statistically significant decreases in pain, assessed by changes in visual analog scale scores, were notes in the legs, when walking, and in overall lifestyle. The use of narcotic medication decreased at all follow-up periods. At least 66% of the patients who were taking narcotics before spinal cord stimulation were taking reduced amounts or no narcotics 2 years later. At the time of the 24-month follow-up, at least 70% of patients reported that the procedure helped them, and would recommend it to someone with similar symptoms. Conclusions. Spinal cord stimulation implantation can result in improved physical function and decreased pain in patients who are carefully screened and in whom the implantation is performed with the patient awake to help ensure optimal pain-relieving lead placement.