BACKGROUND: Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies, and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are described as pain radiating to the lower extremities that begins and worsens as the patient ambulates. Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root. OBJECTIVE: To assess patient safety, pain reduction, and functional status of patients treated with percutaneous lumbar decompression. STUDY DESIGN: Single-center, prospective clinical study of 46 consecutive patients with neurogenic claudication symptoms related to lumbar spinal stenosis. SETTING: US interventional pain management practice. METHODS: From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year follow-up was available for 35 patients. OUTCOME ASSESSMENT: Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one-year follow-ups. RESULTS: One-year follow-up patients in this study experienced statistically and clinically significant improvement in physical function, as well as reduction of pain intensity. The initial improvement in these patients, which was significant, was sustained through one year, with no significant differences among the interim follow-up visit periods. These results demonstrate early improvement following treatment with a high degree of durability over time. There were no serious device or procedure-related complications reported in this study. LIMITATIONS: Single-center study with no control group. CONCLUSIONS: In this study, the mild procedure was shown to be safe. In addition, patients experienced significant improvement in mobility and reduction of pain one year after the procedure. One-year outcomes were not significantly different from interim results, indicating that the significant improvement following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment of neurogenic claudication in symptomatic LSS.
BACKGROUND: Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies, and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are described as pain radiating to the lower extremities that begins and worsens as the patient ambulates. Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root. OBJECTIVE: To assess patient safety, pain reduction, and functional status of patients treated with percutaneous lumbar decompression. STUDY DESIGN: Single-center, prospective clinical study of 46 consecutive patients with neurogenic claudication symptoms related to lumbar spinal stenosis. SETTING: US interventional pain management practice. METHODS: From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year follow-up was available for 35 patients. OUTCOME ASSESSMENT: Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one-year follow-ups. RESULTS: One-year follow-up patients in this study experienced statistically and clinically significant improvement in physical function, as well as reduction of pain intensity. The initial improvement in these patients, which was significant, was sustained through one year, with no significant differences among the interim follow-up visit periods. These results demonstrate early improvement following treatment with a high degree of durability over time. There were no serious device or procedure-related complications reported in this study. LIMITATIONS: Single-center study with no control group. CONCLUSIONS: In this study, the mild procedure was shown to be safe. In addition, patients experienced significant improvement in mobility and reduction of pain one year after the procedure. One-year outcomes were not significantly different from interim results, indicating that the significant improvement following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment of neurogenic claudication in symptomatic LSS.
Authors: Timothy R Deer; Jay S Grider; Jason E Pope; Tim J Lamer; Sayed E Wahezi; Jonathan M Hagedorn; Steven Falowski; Reda Tolba; Jay M Shah; Natalie Strand; Alex Escobar; Mark Malinowski; Anjum Bux; Navdeep Jassal; Jennifer Hah; Jacqueline Weisbein; Nestor D Tomycz; Jessica Jameson; Erika A Petersen; Dawood Sayed Journal: J Pain Res Date: 2022-05-05 Impact factor: 2.832
Authors: Carolina G Fritsch; Manuela L Ferreira; Christopher G Maher; Robert D Herbert; Rafael Z Pinto; Bart Koes; Paulo H Ferreira Journal: Eur Spine J Date: 2016-07-21 Impact factor: 3.134
Authors: Nagy A Mekhail; Shrif J Costandi; Sherif Armanyous; Ricardo Vallejo; Lawrence R Poree; Lora L Brown; Stanley Golovac; Timothy R Deer Journal: Med Devices (Auckl) Date: 2020-06-04