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
Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical managem...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2542454822000297 |
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| author | Erika A. Petersen, MD Thomas G. Stauss, MD James A. Scowcroft, MD Elizabeth S. Brooks, PhD Judith L. White, MD Shawn M. Sills, MD Kasra Amirdelfan, MD Maged N. Guirguis, MD Jijun Xu, MD, PhD Cong Yu, MD Ali Nairizi, MD Denis G. Patterson, DO Kostandinos C. Tsoulfas, MD Michael J. Creamer, DO Vincent Galan, MD Richard H. Bundschu, MD Neel D. Mehta, MD Dawood Sayed, MD Shivanand P. Lad, MD, PhD David J. DiBenedetto, MD Khalid A. Sethi, MD Johnathan H. Goree, MD Matthew T. Bennett, MD Nathan J. Harrison, MD Atef F. Israel, MD Paul Chang, MD Paul W. Wu, MD Charles E. Argoff, MD Christian E. Nasr, MD Rod S. Taylor, PhD David L. Caraway, MD, PhD Nagy A. Mekhail, MD, PhD |
| author_facet | Erika A. Petersen, MD Thomas G. Stauss, MD James A. Scowcroft, MD Elizabeth S. Brooks, PhD Judith L. White, MD Shawn M. Sills, MD Kasra Amirdelfan, MD Maged N. Guirguis, MD Jijun Xu, MD, PhD Cong Yu, MD Ali Nairizi, MD Denis G. Patterson, DO Kostandinos C. Tsoulfas, MD Michael J. Creamer, DO Vincent Galan, MD Richard H. Bundschu, MD Neel D. Mehta, MD Dawood Sayed, MD Shivanand P. Lad, MD, PhD David J. DiBenedetto, MD Khalid A. Sethi, MD Johnathan H. Goree, MD Matthew T. Bennett, MD Nathan J. Harrison, MD Atef F. Israel, MD Paul Chang, MD Paul W. Wu, MD Charles E. Argoff, MD Christian E. Nasr, MD Rod S. Taylor, PhD David L. Caraway, MD, PhD Nagy A. Mekhail, MD, PhD |
| author_sort | Erika A. Petersen, MD |
| collection | DOAJ |
| description | Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were “satisfied” or “very satisfied” with the 10-kHz SCS treatment. Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. Trial registration: clincaltrials.gov Identifier: NCT03228420 |
| first_indexed | 2024-04-11T22:40:45Z |
| format | Article |
| id | doaj.art-7daa218aa0734b449a9c83190d92165e |
| institution | Directory Open Access Journal |
| issn | 2542-4548 |
| language | English |
| last_indexed | 2024-04-11T22:40:45Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| spelling | doaj.art-7daa218aa0734b449a9c83190d92165e2022-12-22T03:59:00ZengElsevierMayo Clinic Proceedings: Innovations, Quality & Outcomes2542-45482022-08-0164347360High-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 TrialErika A. Petersen, MD0Thomas G. Stauss, MD1James A. Scowcroft, MD2Elizabeth S. Brooks, PhD3Judith L. White, MD4Shawn M. Sills, MD5Kasra Amirdelfan, MD6Maged N. Guirguis, MD7Jijun Xu, MD, PhD8Cong Yu, MD9Ali Nairizi, MD10Denis G. Patterson, DO11Kostandinos C. Tsoulfas, MD12Michael J. Creamer, DO13Vincent Galan, MD14Richard H. Bundschu, MD15Neel D. Mehta, MD16Dawood Sayed, MD17Shivanand P. Lad, MD, PhD18David J. DiBenedetto, MD19Khalid A. Sethi, MD20Johnathan H. Goree, MD21Matthew T. Bennett, MD22Nathan J. Harrison, MD23Atef F. Israel, MD24Paul Chang, MD25Paul W. Wu, MD26Charles E. Argoff, MD27Christian E. Nasr, MD28Rod S. Taylor, PhD29David L. Caraway, MD, PhD30Nagy A. Mekhail, MD, PhD31Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock; Correspondence: Address to Erika A. Petersen, MD, Department of Neurosurgery, University of Arkansas for Medical Sciences, 4301 W Markham St, Little Rock, AR 72205.Advanced Pain Management, Greenfield, WIPain Management Associates, Lee’s Summit, MONevro Corp, Redwood City, CAAES Compass Orlando, Orlando, FLTouchstone Interventional Pain Center, Medford, ORIPM Medical Group, Walnut Creek, CAOchsner Health System, New Orleans, LADepartment of Pain Management, Cleveland Clinic Foundation, Cleveland, OHSwedish Medical Center, Seattle, WANevada Advanced Pain Specialists, Reno, NVNevada Advanced Pain Specialists, Reno, NVAdvanced Pain Management, Greenfield, WICentral Florida Pain Relief Centers, Orlando, FLPain Care, Stockbridge, GACoastal Orthopedics and Sports Medicine, Bradenton, FLDepartment of Anesthesiology, Weill Cornell Medical College, New York, NYDepartment of Anesthesiology and Pain Medicine, University of Kansas Medical Center, Kansas City, KSDepartment of Neurosurgery, Duke University, Durham, NCBoston PainCare, Waltham, MADepartment of Neurosurgery, United Health Services, Johnson City, NYDepartment of Anesthesiology, University of Arkansas for Medical Sciences, Little RockDepartment of Neurosurgery, United Health Services, Johnson City, NYOchsner Health System, New Orleans, LAPain Management Associates, Lee’s Summit, MOPain Care, Stockbridge, GAHoly Cross Hospital, Fort Lauderdale, FLDepartment of Neurology, Albany Medical Center, Albany, NYDepartment of Endocrinology, Cleveland Clinic Foundation, Cleveland, OHMRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, United KingdomNevro Corp, Redwood City, CADepartment of Pain Management, Cleveland Clinic Foundation, Cleveland, OHObjective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were “satisfied” or “very satisfied” with the 10-kHz SCS treatment. Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. Trial registration: clincaltrials.gov Identifier: NCT03228420http://www.sciencedirect.com/science/article/pii/S2542454822000297 |
| spellingShingle | Erika A. Petersen, MD Thomas G. Stauss, MD James A. Scowcroft, MD Elizabeth S. Brooks, PhD Judith L. White, MD Shawn M. Sills, MD Kasra Amirdelfan, MD Maged N. Guirguis, MD Jijun Xu, MD, PhD Cong Yu, MD Ali Nairizi, MD Denis G. Patterson, DO Kostandinos C. Tsoulfas, MD Michael J. Creamer, DO Vincent Galan, MD Richard H. Bundschu, MD Neel D. Mehta, MD Dawood Sayed, MD Shivanand P. Lad, MD, PhD David J. DiBenedetto, MD Khalid A. Sethi, MD Johnathan H. Goree, MD Matthew T. Bennett, MD Nathan J. Harrison, MD Atef F. Israel, MD Paul Chang, MD Paul W. Wu, MD Charles E. Argoff, MD Christian E. Nasr, MD Rod S. Taylor, PhD David L. Caraway, MD, PhD Nagy A. Mekhail, MD, PhD 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 Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://www.sciencedirect.com/science/article/pii/S2542454822000297 |
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