Safety and Efficacy of Percutaneous Neuromodulation Therapy in the Management of Subacute Radiating Low Back Pain

Abstract

Percutaneous neuromodulation therapy (PNT) is a new minimally invasive, office-based treatment for low back pain in which electrical stimulation is delivered to the paraspinal peripheral nerves. The purpose of this study was to determine the safety, tolerability, and clinical efficacy of PNT in a population of patients with subacute low back pain with radiation to the lower extremity. Open label prospective clinical trial. Multi-center outpatient setting. We enrolled 83 patients who had radiating low back pain for 4 weeks to 6 months with a pain intensity of at least 4 on a visual analog scale of 0-10. Subjects were treated with PNT 1 to 2 times per week for at least 4 weeks. Based on clinical response patients were treated up to an additional 8 weeks. We recorded baseline visual analog scale (VAS) scores of radiating pain, low back pain, physical activity, and sleep, as well as the Oswestry Disability Questionnaire. Follow-up assessments were performed at each session, and at 5 and 12 weeks. Patients benefiting from treatments at 12 weeks were followed-up at 6 months. Fifty-nine patients completed the study protocol. Mean VAS scores improved as follows: leg/buttock pain decreased by 37% to 4.0 +/- 2.6 from a baseline of 6.6 +/- 1.7 (P < 0.001); low back pain decreased by 26% to 3.9 +/- 2.4 from a baseline of 5.5 +/- 2.2 (P < 0.001); activity levels improved by 38% to 3.6 +/- 2.2 from a baseline of 6.0 +/- 2.2 (P < 0.001); and sleep improved by 27% to 3.1 +/- 2.5 from a baseline of 4.8 +/- 3.0 (P < 0.001). The Oswestry Low Back Pain Disability scores improved by 24% to 32 +/- 16 from a baseline of 43 +/- 15 (P < 0.001). Pain relief was sustained over a 3-month observation period. For many patients with subacute radiating low back pain, PNT significantly reduced pain and self-rated disability, and improved sleep quality and activity level. PNT is safe and generally well tolerated.