Publications (2)4.72 Total impact
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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. Setting: 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.
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ABSTRACT: Percutaneous neuromodulation therapy (PNT) is a minimally invasive approach to the treatment of low back pain (LBP), involving electrical stimulation applied to percutaneous electrodes placed within the lumbar paraspinal tissues during 30-minute treatment sessions. This study reports the effects of PNT on a population of patients with chronic and severe levels of LBP. This study was performed in an outpatient clinical research setting. Thirty-nine patients were enrolled who had stable levels of LBP lasting at least 6 months, with enrollment LBP visual analog scale (VAS) scores of at least 5 on a scale of 10. The patients were treated with PNT 2 times per week for 4 weeks. Baseline VAS scores of LBP, physical activity, sleep, and the Oswestry Questionnaire were recorded. The final assessment was made 48 hours after the last treatment. After 4 sessions, the patients completed a “responder screen” questionnaire whereby, to continue treatment, they had to indicate both a perceived benefit and improvement in LBP and/or activity levels. Thirty-one patients completed the study protocol. Of the 18 patients (58% of 31) who passed the responder screen, 14 (78% of 18, 45% of 31) had ≥30% improvement in LBP and/or activity levels. Mean LBP scores decreased by 37% to 4.5 ± 2.2 from 7.1 ± 1.0 (P=0.0001); activity scores improved by 39% to 4.0 ± 2.1 from 6.7 ± 1.5 (P=0.0005); sleep scores improved by 40% from 6.2 ± 2.6 to 4.0 ± 2.6 (P=0.0003). Oswestry scores improved from 44 ± 12 to 33 ± 15 (P=0.002). In conclusion, for patients with chronic and severe stable levels of low back pain, PNT appears promising for pain level reduction and improvement in function.
Norwalk HospitalNorwalk, Connecticut, United States