OBJECTIVES: To examine the feasibility of novel high-frequency spinal cord stimulation therapy in a cohort of patients with chronic predominant back pain during a four day, percutaneous trial. DESIGN: Prospective, multicenter open label pilot trial. SETTING AND PATIENTS: Twenty-four patients with back pain greater than leg pain who were candidates for spinal cord stimulation were trialed at five U.S. centers. INTERVENTIONS: Patients completed a percutaneous trial with a commercially available spinal cord stimulator. The implanted leads were then connected to the novel external stimulation device and patients were trialed for an additional four days. OUTCOME MEASURES: Pain intensity ratings, subjective descriptions, and patients' preference. RESULTS: There was significant improvement from baseline in overall pain scores (8.68 to 2.03, [p < 0.001]) and back pain scores (8.12 to 1.88, [p < 0.001]) with the investigational stimulation. The investigational stimulation was preferred to the commercially available systems in 21 of 24 patients (88%). CONCLUSIONS: Patients with predominant back pain reported a substantial reduction in overall pain and back pain when trialed with high-frequency spinal cord stimulation therapy.
OBJECTIVES: To examine the feasibility of novel high-frequency spinal cord stimulation therapy in a cohort of patients with chronic predominant back pain during a four day, percutaneous trial. DESIGN: Prospective, multicenter open label pilot trial. SETTING AND PATIENTS: Twenty-four patients with back pain greater than leg pain who were candidates for spinal cord stimulation were trialed at five U.S. centers. INTERVENTIONS: Patients completed a percutaneous trial with a commercially available spinal cord stimulator. The implanted leads were then connected to the novel external stimulation device and patients were trialed for an additional four days. OUTCOME MEASURES: Pain intensity ratings, subjective descriptions, and patients' preference. RESULTS: There was significant improvement from baseline in overall pain scores (8.68 to 2.03, [p < 0.001]) and back pain scores (8.12 to 1.88, [p < 0.001]) with the investigational stimulation. The investigational stimulation was preferred to the commercially available systems in 21 of 24 patients (88%). CONCLUSIONS: Patients with predominant back pain reported a substantial reduction in overall pain and back pain when trialed with high-frequency spinal cord stimulation therapy.
Authors: Leah Marie Roldan; Thomas E Eggers; Kevin L Kilgore; Narendra Bhadra; Tina Vrabec; Niloy Bhadra Journal: J Neurosci Methods Date: 2019-01-11 Impact factor: 2.390