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1. Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial

Author

Petersen, Erika A., Stauss, Thomas G., Scowcroft, James A., Jaasma, Michael J., Brooks, Elizabeth S., Edgar, Deborah R., White, Judith L., Sills, Shawn M., Amirdelfan, Kasra, Guirguis, Maged N., Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis G., Tsoulfas, Kostandinos C., Creamer, Michael J., Galan, Vincent, Bundschu, Richard H., Mehta, Neel D., Sayed, Dawood, Lad, Shivanand P., DiBenedetto, David J., Sethi, Khalid A., Goree, Johnathan H., Bennett, Matthew T., Harrison, Nathan J., Israel, Atef F., Chang, Paul, Wu, Paul W., Argoff, Charles E., Nasr, Christian E., Taylor, Rod S., Caraway, David L., and Mekhail, Nagy A.

Published
2023
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2. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial

Author

Petersen, Erika A., Stauss, Thomas G., Scowcroft, James A., Brooks, Elizabeth S., White, Judith L., Sills, Shawn M., Amirdelfan, Kasra, Guirguis, Maged N., Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis G., Tsoulfas, Kostandinos C., Creamer, Michael J., Galan, Vincent, Bundschu, Richard H., Mehta, Neel D., Sayed, Dawood, Lad, Shivanand P., DiBenedetto, David J., Sethi, Khalid A., Goree, Johnathan H., Bennett, Matthew T., Harrison, Nathan J., Israel, Atef F., Chang, Paul, Wu, Paul W., Argoff, Charles E., Nasr, Christian E., Taylor, Rod S., Caraway, David L., and Mekhail, Nagy A.

Published
2022
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3. 127 Durable Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation

Author

Petersen, Erika A., primary, Stauss, Thomas, additional, Scowcroft, James, additional, Jaasma, Michael, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Nandan P., additional, DiBenedetto, David, additional, Creamer, Michael, additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod S., additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2024
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4. EP076 / #259 THE DURABILITY OF 10 KHZ SCS THERAPY IN PATIENTS WITH PAINFUL DIABETIC NEUROPATHY

Author

Petersen, Erika, primary, Stauss, Thomas, additional, Scowcroft, James, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Shivanand, additional, Dibenedetto, David, additional, Sethi, Khalid, additional, Wu, Paul, additional, Argoff, Charles, additional, Jaasma, Michael, additional, Chowdhury, Shibasis, additional, Caraway, David, additional, Nasr, Christian, additional, Taylor, Rod, additional, Mekhail, Nagy, additional, and Creamer, Michael, additional

Published
2023
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5. Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results

Author

Falowski,Steven M, Raso,Louis, Mangal,Vipul, Nairizi,Ali, Patterson,Denis, Danko,Michael D, Justiz,Rafael, Vogel,Rainer S, Koga,Sebastian, Josephson,Yousseff, Pope,Jason E, Raji,Oluwatodimu Richard, Falowski,Steven M, Raso,Louis, Mangal,Vipul, Nairizi,Ali, Patterson,Denis, Danko,Michael D, Justiz,Rafael, Vogel,Rainer S, Koga,Sebastian, Josephson,Yousseff, Pope,Jason E, and Raji,Oluwatodimu Richard

Abstract

Steven M Falowski,1,* Louis J Raso,2 Vipul Mangal,3 Ali Nairizi,4 Denis G Patterson,5 Michael D Danko,6 Rafael Justiz,7 Rainer S Vogel,8 Sebastian Koga,9 Yousseff Josephson,10 Jason E Pope,11,* Oluwatodimu Richard Raji12 1Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 2Jupiter Medical Center, Jupiter, FL, USA; 3National Spine and Pain Centers, Oxon Hill, MD, USA; 4Reno Tahoe Pain Associates, Reno, NV, USA; 5Nevada Pain Specialists, Reno, NV, USA; 6Premier Pain Treatment Institute, Loveland, OH, USA; 7Oklahoma Pain Physicians, Oklahoma City, OK, USA; 8Comprehensive and Interventional Pain Management, Henderson, NV, USA; 9Koga Neurosurgery, Covington, LA, USA; 10National Spine and Pain Centers, Voorhees, NJ, USA; 11Evolve Restorative Center, Santa Rosa, CA, USA; 12Medical Device Development, San Francisco, CA, USA*These authors contributed equally to this workCorrespondence: Oluwatodimu Richard Raji, Medical Device Development, 2390 Mission Street, Suite 8, San Francisco, CA, 94110, USA, Tel +15105707741, Email richardraji@mdevdev.comPurpose: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.Patients and Methods: This study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, an

Published
2023

6. Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results.

Author

Falowski, Steven M, Raso, Louis J, Mangal, Vipul, Nairizi, Ali, Patterson, Denis G, Danko, Michael D, Justiz, Rafael, Vogel, Rainer S, Koga, Sebastian, Josephson, Yousseff, Pope, Jason E, and Raji, Oluwatodimu Richard

Subjects
LUMBAR pain, ANALGESIA, FUNCTIONAL status, SURGICAL decompression, SPINAL stenosis, LEG pain, VISUAL analog scale
Abstract

Purpose: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.Patients and Methods: This study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire (ZCQ), and secondarily using the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. The safety endpoints were the adverse events and reoperations or revisions at the index level(s).Results: At 6-month post-op, 76%, 62%– 64%, and 64% of patients demonstrated clinical meaningful, and statistically significant improvement in their pain as defined by ZCQ, VAS (back and leg), and ODI, respectively. In addition, 78% of patients noted improvement in PGIC. Two procedure-related adverse events were noted which fully resolved without surgical intervention.Conclusion: This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the interspinous fusion device. Our analysis showed a sustained improvement in clinical efficacy, and safety endpoints, when compared to the 3-months evaluations, across both interventional pain and neurosurgery specialties. [ABSTRACT FROM AUTHOR]

Published
2023
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7. 440 10 kHz Spinal Cord Stimulation (SCS) Provides Significant, Durable Pain Relief for Patients with Painful Diabetic Neuropathy (PDN): 24-Month Results

Author

Petersen, Erika A., primary, Stauss, Thomas, additional, Scowcroft, James, additional, Jaasma, Michael, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Creamer, Michael, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Nandan P., additional, DiBenedetto, David, additional, Sethi, Khalid Ahmed, additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod, additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2023
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8. A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)

Author

Pope, Jason E., primary, Jassal, Navdeep, additional, Sayed, Dawood, additional, Patterson, Denis, additional, McDowell, Gladstone, additional, Bux, Anjum, additional, Lim, Phillip, additional, Chang, Eric, additional, Nairizi, Ali, additional, Grodofsky, Samuel, additional, and Deer, Timothy R, additional

Published
2022
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9. O052 / #884 10-KHZ SPINAL CORD STIMULATION IS A DURABLE TREATMENT FOR PAINFUL DIABETIC NEUROPATHY: LONG-TERM MULTICENTER RANDOMIZED CONTROLLED TRIAL RESULTS

Author

Petersen, Erika, primary, Stauss, Thomas, additional, Scowcroft, James, additional, Brooks, Elizabeth, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Shivanand, additional, Dibenedetto, David, additional, Sethi, Khalid, additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod, additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2022
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10. ID: 314835 Painful Diabetic Neuropathy: 10 kHz SCS Provides Significant, Durable Improvements in Quality of Life Metrics

Author

Petersen, Erika, Stauss, Thomas, Scowcroft, James, Jaasma, Michael, White, Judith, Sills, Shawn, Amirdelfan, Kasra, Guirguis, Maged, Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis, Galan, Vincent, Bundschu, Richard, Mehta, Neel, Sayed, Dawood, Lad, Shivanand, DiBenedetto, David, Creamer, Michael, Wu, Paul, Argoff, Charles, Nasr, Christian, Taylor, Rod, Caraway, David, and Mekhail, Nagy

Published
2024
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11. O044 10 KHZ SCS PROVIDES EFFECTIVE LONG-TERM TREATMENT OF PAINFUL DIABETIC NEUROPATHY

Author

Petersen, Erika, Stauss, Thomas, Scowcroft, James, Jaasma, Michael, White, Judith, Sills, Shawn, Amirdelfan, Kasra, Guirguis, Maged, Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis, Galan, Vincent, Bundschu, Richard, Mehta, Neel, Sayed, Dawood, Lad, Nandan, Dibenedetto, David, Creamer, Michael, Wu, Paul, Argoff, Charles, Nasr, Christian, Taylor, Rod, Caraway, David, and Mekhail, Nagy

Published
2025
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12. 22-LB: 24-Month Results for 10-kHz Spinal Cord Stimulation (SCS) in Treating Painful Diabetic Neuropathy (PDN)

Author

PETERSEN, ERIKA, primary, STAUSS, THOMAS G., additional, SCOWCROFT, JAMES A., additional, BROOKS, ELIZABETH, additional, WHITE, JUDITH L., additional, SILLS, SHAWN M., additional, AMIRDELFAN, KASRA, additional, GUIRGUIS, MAGED, additional, XU, JIJUN, additional, YU, CONG, additional, NAIRIZI, ALI, additional, PATTERSON, DENIS G., additional, GALAN, VINCENT, additional, BUNDSCHU, RICHARD, additional, MEHTA, NEEL, additional, SAYED, DAWOOD, additional, DIBENEDETTO, DAVID, additional, SETHI, KHALID A., additional, WU, PAUL W., additional, ARGOFF, CHARLES, additional, NASR, CHRISTIAN E., additional, TAYLOR, ROD, additional, and CARAWAY, DAVID L., additional

Published
2022
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13. Durability of 10-kHz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 18-Month Multicenter Randomized Controlled Trial Results (P1-1.Virtual)

Author

Petersen, Erika, primary, Stauss, Thomas, additional, Scowcroft, James, additional, Brooks, Elizabeth, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Shivanand Pramod, additional, DiBenedetto, David, additional, Sethi, Khalid, additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod, additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2022
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14. 123 Long-Term High-Frequency (10 kHz) Spinal Cord Stimulation in Painful Diabetic Neuropathy - A Randomized Controlled Trial

Author

Petersen, Erika A., primary, Stauss, Thomas, additional, Scowcroft, James, additional, Brooks, Elizabeth, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Nandan P., additional, DiBenedetto, David, additional, Sethi, Khalid A., additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod S., additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2022
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15. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial

Author

Petersen, Erika A., primary, Stauss, Thomas G., additional, Scowcroft, James A., additional, Brooks, Elizabeth S., additional, White, Judith L., additional, Sills, Shawn M., additional, Amirdelfan, Kasra, additional, Guirguis, Maged N., additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis G., additional, Tsoulfas, Kostandinos C., additional, Creamer, Michael J., additional, Galan, Vincent, additional, Bundschu, Richard H., additional, Mehta, Neel D., additional, Sayed, Dawood, additional, Lad, Shivanand P., additional, DiBenedetto, David J., additional, Sethi, Khalid A., additional, Goree, Johnathan H., additional, Bennett, Matthew T., additional, Harrison, Nathan J., additional, Israel, Atef F., additional, Chang, Paul, additional, Wu, Paul W., additional, Argoff, Charles E., additional, Nasr, Christian E., additional, Taylor, Rod S., additional, Caraway, David L., additional, and Mekhail, Nagy A., additional

Published
2021
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17. A randomized controlled trial of high frequency (10 kHz) spinal cord stimulation in painful\ud diabetic neuropathy

Author

Petersen, Erika A., Stauss, Thomas G., Scowcroft, James A., Brooks, Elizabeth S., White, Judith L., Sills, Shawn M., Amirdelfan, Kasra, Guirguis, Maged N., Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis G., Tsoulfas, Kostandinos C., Creamer, Michael J., Galan, Vincent, Bundschu, Richard H., Paul, Christopher A, Mehta, Neel D., Choi, Heejung, Sayed, Dawood, Lad, Shivanand P., DiBenedetto, David J., Sethi, Khalid A., Goree, Johnathan H., Bennett, Matthew T., Harrison, Nathan J., Israel, Atef F., Chang, Paul, Wu, Paul W., Gekht, Gennady, Argoff, Charles E., Nasr, Christian E., Taylor, Rod S., Subbaroyan, Jeyakumar, Gliner, Bradford E., Caraway, David L., and Mekhail, Nagy A.

Abstract

Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.\ud \ud Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).\ud \ud Design, Setting, and Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.\ud \ud Interventions: Implanted medical device delivering 10-kHz SCS.\ud \ud Main Outcomes and Measures: The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months.\ud \ud Results: Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P

Published
2021

18. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy

Author

Petersen, Erika A., primary, Stauss, Thomas G., additional, Scowcroft, James A., additional, Brooks, Elizabeth S., additional, White, Judith L., additional, Sills, Shawn M., additional, Amirdelfan, Kasra, additional, Guirguis, Maged N., additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis G., additional, Tsoulfas, Kostandinos C., additional, Creamer, Michael J., additional, Galan, Vincent, additional, Bundschu, Richard H., additional, Paul, Christopher A., additional, Mehta, Neel D., additional, Choi, Heejung, additional, Sayed, Dawood, additional, Lad, Shivanand P., additional, DiBenedetto, David J., additional, Sethi, Khalid A., additional, Goree, Johnathan H., additional, Bennett, Matthew T., additional, Harrison, Nathan J., additional, Israel, Atef F., additional, Chang, Paul, additional, Wu, Paul W., additional, Gekht, Gennady, additional, Argoff, Charles E., additional, Nasr, Christian E., additional, Taylor, Rod S., additional, Subbaroyan, Jeyakumar, additional, Gliner, Bradford E., additional, Caraway, David L., additional, and Mekhail, Nagy A., additional

Published
2021
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19. Sustained Benefits for 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy - Six Month Results from a Multicenter Randomized Controlled Trial (4879)

Author

Petersen, Erika, primary, Stauss, Thomas, additional, Scowcroft, James, additional, Brooks, Elizabeth, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfan, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Shivanand Pramod, additional, DiBenedetto, David, additional, Sethi, Khalid, additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod, additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2021
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20. ID: 200637 10 kHz SCS Provides Durable Pain Relief for Patients With Painful Diabetic Neuropathy

Author

Petersen, Erika, Stauss, Thomas, Scowcroft, James, Jaasma, Michael, White, Judith, Sills, Shawn, Amirdelfan, Kasra, Guirguis, Maged, Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis, Galan, Vincent, Bundschu, Richard, Mehta, Neel, Sayed, Dawood, Lad, Shivanand, DiBenedetto, David, Creamer, Michael, Wu, Paul, Argoff, Charles, Nasr, Christian, Taylor, Rod, Caraway, David, and Mekhail, Nagy

Published
2023
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21. ID: 205709 10 kHz SCS Significantly Improves Health-Related Quality of Life for Patients With Painful Diabetic Neuropathy

Author

Petersen, Erika, Stauss, Thomas, Scowcroft, James, Jaasma, Michael, White, Judith, Sills, Shawn, Amirdelfan, Kasra, Guirguis, Maged, Xu, Jijun, Yu, Cong, Nairizi, Ali, Patterson, Denis, Galan, Vincent, Bundschu, Richard, Mehta, Neel, Sayed, Dawood, Lad, Shivanand, DiBenedetto, David, Creamer, Michael, Wu, Paul, Argoff, Charles, Nasr, Christian, Taylor, Rod, Caraway, David, and Mekhail, Nagy

Published
2023
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22. 10 kHz Spinal Cord Stimulation for Treatment of Painful Diabetic Neuropathy - A Multicenter Randomized Controlled Trial

Author

Petersen, Erika A, primary, Stauss, Thomas, additional, Scowcroft, James, additional, White, Judith, additional, Sills, Shawn, additional, Amirdelfa, Kasra, additional, Guirguis, Maged, additional, Xu, Jijun, additional, Yu, Cong, additional, Nairizi, Ali, additional, Patterson, Denis, additional, Galan, Vincent, additional, Bundschu, Richard, additional, Mehta, Neel, additional, Sayed, Dawood, additional, Lad, Nandan P, additional, DiBenedetto, David, additional, Sethi, Khalid A, additional, Wu, Paul, additional, Argoff, Charles, additional, Nasr, Christian, additional, Taylor, Rod, additional, Brooks, Elizabeth, additional, Subbaroyan, Jey, additional, Gliner, Bradford E, additional, Caraway, David, additional, and Mekhail, Nagy, additional

Published
2020
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23. 31-LB: Neuromodulation for Treatment of Painful Diabetic Neuropathy: A Multicenter Randomized Controlled Trial

Author

PETERSEN, ERIKA, primary, STAUSS, THOMAS, additional, WHITE, JUDITH L., additional, SILLS, SHAWN M., additional, AMIRDELFAN, KASRA, additional, GUIRGUIS, MAGED, additional, XU, JIJUN, additional, YU, CONG, additional, NAIRIZI, ALI, additional, PATTERSON, DENIS G., additional, GALAN, VINCENT, additional, MEHTA, NEEL, additional, LAD, SHIVANAND P., additional, DIBENEDETTO, DAVID, additional, WU, PAUL W., additional, NASR, CHRISTIAN E., additional, TAYLOR, ROD, additional, BROOKS, ELIZABETH S., additional, SUBBAROYAN, JEYAKUMAR, additional, GLINER, BRADFORD, additional, CARAWAY, DAVID L., additional, and MEKHAIL, NAGY, additional

Published
2020
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24. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial.

Author

Petersen, Erika A., Stauss, Thomas G., Scowcroft, James A., Brooks, Elizabeth S., White, Judith L., Sills, Shawn M., Amirdelfan, Kasra, Guirguis, Maged N., Jijun Xu, Cong Yu, Nairizi, Ali, Patterson, Denis G., Tsoulfas, Kostandinos C., Creamer, Michael J., Galan, Vincent, Bundschu, Richard H., Mehta, Neel D., Sayed, Dawood, Lad, Shivanand P., and DiBenedetto, David J.

Subjects
SPINAL cord, DIABETIC neuropathies, RANDOMIZED controlled trials, ANALGESIA, PEOPLE with diabetes, LEG pain
Abstract

The article discusses the durability of high-frequency 10-khz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments with 12-month results from a randomized controlled trial. Topics include diabetes will develop painful diabetic neuropathy (PDN) with paresthesia, burning, and shooting pain; and Therapeutic goals include symptom management along with behavioral modifications to mitigate damage.

Published
2022
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27. Durability of 10-khz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 18-month Multicenter Randomized Controlled Trial Results.

Author

Petersen, Erika A., Stauss, Thomas, Scowcroft, James, Brooks, Elizabeth, White, Judith, Sills, Shawn, Amirdelfan, Kasra, Guirguis, Maged, Jijun Xu, Cong Yu, Nairizi, Ali, Patterson, Denis, Galan, Vincent, Bundschu, Richard, Mehta, Neel, Sayed, Dawood, Lad, Shivanand, DiBenedetto, David, Sethi, Khalid, and Wu, Paul

Published
2022
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28. High-Frequency 10-kHz Spinal Cord Stimulation Provides Long-term (24-Month) Improvements in Diabetes-Related Pain and Quality of Life for Patients with Painful Diabetic Neuropathy.

Author

Petersen EA, Stauss TG, Scowcroft JA, Jaasma MJ, Edgar DR, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, and Mekhail NA

Abstract

Background: The SENZA-PDN study evaluated high-frequency 10-kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). Over 24 months, 10-kHz SCS provided sustained pain relief and improved health-related quality of life. This report presents additional outcomes from the SENZA-PDN study, focusing on diabetes-related pain and quality of life outcomes., Methods: The SENZA-PDN study randomized 216 participants with refractory PDN to receive either conventional medical management (CMM) or 10-kHz SCS plus CMM (10-kHz SCS + CMM), allowing crossover after six months if pain relief was insufficient. Postimplantation assessments at 24 months were completed by 142 participants with a permanent 10-kHz SCS implant, comprising 84 initial and 58 crossover recipients. Measures included the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Diabetes-Related Quality of Life (DQOL), Global Assessment of Functioning (GAF), and treatment satisfaction., Results: Over 24 months, 10-kHz SCS treatment significantly reduced pain severity by 66.9% ( P < .001; BPI-DPN) and pain interference with mood and daily activities by 65.8% ( P < .001; BPI-DPN). Significant improvements were also observed in overall DQOL score ( P < .001) and GAF score ( P < .001), and 91.5% of participants reported satisfaction with treatment., Conclusions: High-frequency 10-kHz SCS significantly decreased pain severity and provided additional clinically meaningful improvements in DQOL and overall functioning for patients with PDN. The robust and sustained benefits over 24 months, coupled with high participant satisfaction, highlight that 10-kHz SCS is an efficacious and comprehensive therapy for patients with PDN., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EAP has received consulting fees from Abbott Laboratories, Biotronik, Boston Scientific, Medtronic Neuromodulation, Nalu Medical, Neuros Medical, Nevro Corp, Presidio Medical, Saluda, and Vertos Medical; research support from Mainstay, Medtronic Neuromodulation, Nalu Medical, Neuros Medical, Nevro Corp, ReNeuron, Saluda, and SPR; and stock options from neuro42 and SynerFuse. TGS has received research support from Nevro Corp. JAS has received research support from Boston Scientific, Nevro Corp, Saluda Medical, and Vertiflex. MJJ is an employee of Nevro Corp. DRE received a fee from Nevro Corp for the preparation of this manuscript in her capacity as an independent medical writer. JLW has received consulting fees from California Institute for Biomedical Research and Eli Lilly and research support from Nevro Corp. SMS has received research support from Nevro Corp. KA has received consulting fees from Biotronik, Medtronic, Nalu Medical, Nevro Corp, and Saluda Medical, as well as research support from Biotronik, IPM Medical Group, Nevro Corp, Saluda Medical, SPR Therapeutics, and Vivex Biologics. MNG has received consulting fees from Abbott Laboratories, Avanos Medical, Avertis Pharmacy, Boston Scientific, Nevro Corp, and Saluda Medical, as well as research support from Abbott Laboratories, Avanos Medical, Boston Scientific, Nalu Medical, Neuros Medical, Nevro Corp, and Saluda Medical. JX has received research support from the Cleveland Clinic Velosano Program, the National Institutes of Health, the Steve and Melody Golding Foundation, and Nevro Corp. CY has received research support from Nevro Corp. AN has received consulting fees from Aurora Spine, Flowonix, and Nevro Corp, as well as research support from Nevro Corp. DGP has received consulting fees from Abbott Laboratories, AIS Healthcare, Allergan, Amgen, Aurora Spine, CornerLoc, Flowonix, Lundbeck, Pajunk Medical, Saluda Medical, Spark Biomedical, and Vertos Medical; research support from Abbott Laboratories, Aurora Spine, Flowonix, Nevro Corp, and Saluda Medical; speakers’ bureau or honoraria from Abbott Laboratories, Allergan, Amgen, CornerLoc, Lundbeck, Saluda Medical, and Vertos Medical; and stock options from CornerLoc. MJC has received research support from Nevro Corp. VG has received research support from Biotronik, Medtronic, Nevro Corp, PainTEQ, SPR Therapeutics, and St. Jude. RHB has received research support from Nevro Corp. NDM has received consulting fees from Averitas, Nevro Corp, and Salix Pharmaceuticals, as well as research support from Boston Scientific and Nevro Corp. DS has received consulting fees from Abbott Laboratories, Boston Scientific, Flowonix, Medtronic, Nevro Corp, Vertiflex, and Vertos Medical, as well as research support from Abbott Laboratories, Biotronik, Nevro Corp, Vertiflex, and Vertos Medical. SPL has received consulting fees from Nevro Corp and research support from Nevro Corp. DJD has received research support from Nevro Corp, as well as funding for serving as principal investigator of a study supported by SPR Therapeutics paid to his institution. KAS has received research support from Nevro Corp. JHG has received consulting fees from Abbott Laboratories, Saluda Medical, and Stratus Medical. PWW has received research support from Nevro Corp. CEA has received consulting fees from AbbVie, Amgen, Biohaven, Clexio Biosciences, Collegium, Eli Lilly, Elsevier, Flowonix, Gene Pharma, Lundbeck, Nevro Corp, Novartis, Pfizer, SK Life Science, Teva Pharmaceutical, and Vertex, as well as research support from AbbVie, Allergan, Amgen, Daiichi Sankyo, Eli Lilly, Novartis, Teva Pharmaceutical, and Vertex Pharmaceuticals. CEN has received consulting fees from Exelixis, Neurogastrx, and Nevro Corp, as well as research support from Nevro Corp. RST has received consulting fees from Nevro Corp, Medtronic, and Saluda Medical. DLC is an employee of Nevro Corp. NAM has received consulting fees from Nevro Corp, Relievant Medsystems, Saluda Medical, Sollis Therapeutics, and Vertos Medical, as well as research support from Avanos Medical, Mesoblast, Neuros Medical, and Nevro Corp.

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2024
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