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

被引：0

作者：

Petersen, Erika A. ^{[1
]}

Stauss, Thomas G. ^{[2
]}

Scowcroft, James A. ^{[3
]}

Jaasma, Michael J. ^{[4
]}

Edgar, Deborah R. ^{[5
]}

White, Judith L. ^{[6
]}

Sills, Shawn M. ^{[7
]}

Amirdelfan, Kasra ^{[8
]}

Guirguis, Maged N. ^{[9
]}

Xu, Jijun ^{[10
]}

Yu, Cong ^{[11
]}

Nairizi, Ali ^{[12
]}

Patterson, Denis G. ^{[12
]}

Creamer, Michael J. ^{[13
]}

Galan, Vincent ^{[14
]}

Bundschu, Richard H. ^{[15
]}

Mehta, Neel D. ^{[16
]}

Sayed, Dawood ^{[17
]}

Lad, Shivanand P. ^{[18
]}

Dibenedetto, David J. ^{[19
]}

Sethi, Khalid A. ^{[20
]}

Goree, Johnathan H. ^{[21
]}

Bennett, Matthew T. ^{[20
]}

Harrison, Nathan J. ^{[9
]}

Israel, Atef F. ^{[3
]}

Chang, Paul ^{[14
]}

Wu, Paul W. ^{[22
]}

Argoff, Charles E. ^{[23
]}

Nasr, Christian E. ^{[24
]}

Taylor, Rod S. ^{[25
]}

Caraway, David L. ^{[4
]}

Mekhail, Nagy A. ^{[26
]}

机构：

[1] Univ Arkansas Med Sci, Dept Neurosurg, 4301 W Markham St, Little Rock, AR 72205 USA

[2] Adv Pain Management, Greenfield, WI USA

[3] J Marks & Associates, Lees Summit, MO USA

[4] Nevro Corp, Redwood City, CA USA

[5] Stirling Royal Infirm, Stirling, Scotland

[6] AES Compass Orlando, Orlando, FL USA

[7] Touchstone Intervent Pain Ctr, Medford, OR USA

[8] IPM Med Grp, Walnut Creek, CA 94598 USA

[9] Ochsner Hlth Syst, New Orleans, LA USA

[10] Cleveland Clin Fdn, Dept Neurol Surg, Cleveland, OH USA

[11] Swedish Med Ctr, Seattle, WA USA

[12] Nevada Adv Pain Specialists, Reno, NV USA

[13] Cent Florida Pain Relief Ctr, Orlando, FL USA

[14] Pain Care, Stockbridge, GA USA

[15] Coastal Orthoped & Sports Med, Bradenton, FL USA

[16] Weill Cornell Med Coll, Dept Anesthesiol, New York, NY USA

[17] Univ Kansas, Med Ctr, Dept Anesthesiol & Pain Med, Kansas City, KS 66103 USA

[18] Duke Univ, Dept Neurosurg, Durham, NC USA

[19] Boston PainCare, Waltham, MA USA

[20] United Hlth Serv, Dept Neurosurg, Johnson City, NY USA

[21] Univ Arkansas Med Sci, Dept Anesthesiol, Little Rock, AR 72205 USA

[22] Holy Cross Hosp, Ft Lauderdale, FL USA

[23] Albany Med Ctr, Dept Neurol, Albany, NY USA

[24] Univ Arizona, Coll Med Phoenix, Dept Internal Med, Div Endocrinol, Phoenix, AZ USA

[25] Univ Glasgow, Inst Hlth & Well Being, Robertson Ctr Biostat, MRC CSO Social & Publ Hlth Sci Unit, Glasgow, Scotland

[26] Cleveland Clin, Evidence Based Pain Management Res, Cleveland, OH USA

来源：

JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY | 2024年

关键词：

diabetic peripheral neuropathy; diabetes; pain relief; health-related quality of life; neuromodulation; PERIPHERAL NEUROPATHY; SYMPTOM;

D O I：

10.1177/19322968241268547

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：10

共 42 条

[1] Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature [J].

Alleman, Cathelijne J. M. ;

Westerhout, Kirsten Y. ;

Hensen, Marja ;

Chambers, Colette ;

Stoker, Malcolm ;

Long, Stephen ;

van Nooten, Floortje E. .

DIABETES RESEARCH AND CLINICAL PRACTICE, 2015, 109 (02) :215-225

[2]

American Psychiatric Association, 1994, DIAGNOSTIC STAT MANU

[3]

[Anonymous], 2021, Global diabetes data report 2000-2045

[4] Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation [J].

Argoff, Charles E. ;

Armstrong, David G. ;

Kagan, Zachary B. ;

Jaasma, Michael J. ;

Bharara, Manish ;

Bradley, Kerry ;

Caraway, David L. ;

Petersen, Erika A. .

JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY, 2024,

[5] Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial [J].

de Vos, Cecile C. ;

Meier, Kaare ;

Zaalberg, Paul Brocades ;

Nijhuis, Harold J. A. ;

Duyvendak, Wim ;

Vesper, Jan ;

Enggaard, Thomas P. ;

Lenders, Mathieu W. P. M. .

PAIN, 2014, 155 (11) :2426-2431

[6] Pregabalin for neuropathic pain in adults [J].

Derry, Sheena ;

Bell, Rae Frances ;

Straube, Sebastian ;

Wiffen, Philip J. ;

Aldington, Dominic ;

Moore, R. Andrew .

COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2019, (01)

[7] Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations [J].

Dworkin, Robert H. ;

Turk, Dennis C. ;

Wyrwich, Kathleen W. ;

Beaton, Dorcas ;

Cleeland, Charles S. ;

Farrar, John T. ;

Haythornthwaite, Jennifer A. ;

Jensen, Mark P. ;

Kerns, Robert D. ;

Ader, Deborah N. ;

Brandenburg, Nancy ;

Burke, Laurie B. ;

Cella, David ;

Chandler, Julie ;

Cowan, Penny ;

Dimitrova, Rozalina ;

Dionne, Raymond ;

Hertz, Sharon ;

Jadad, Alejandro R. ;

Katz, Nathaniel P. ;

Kehlet, Henrik ;

Kramer, Lynn D. ;

Manning, Donald C. ;

McCormick, Cynthia ;

McDermott, Michael P. ;

McQuay, Henry J. ;

Patel, Sanjay ;

Porter, Linda ;

Quessy, Steve ;

Rappaport, Bob A. ;

Rauschkolb, Christine ;

Revickl, Dennis A. ;

Rothman, Margaret ;

Schmader, Kenneth E. ;

Stacey, Brett R. ;

Stauffer, Joseph W. ;

Von Stein, Thorsten ;

White, Richard E. ;

Witter, James ;

Zavislc, Stojan .

JOURNAL OF PAIN, 2008, 9 (02) :105-121

[8] Pharmacotherapy of neuropathic pain: time to rewrite the rulebook? [J].

Finnerup, Nanna B. ;

Attal, Nadine .

PAIN MANAGEMENT, 2016, 6 (01) :1-3

[9] Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis [J].

Finnerup, Nanna B. ;

Attal, Nadine ;

Haroutounian, Simon ;

McNicol, Ewan ;

Baron, Ralf ;

Dworkin, Robert H. ;

Gilron, Ian ;

Haanpaa, Maija ;

Hansson, Per ;

Jensen, Troels S. ;

Kamerman, Peter R. ;

Lund, Karen ;

Moore, Andrew ;

Raja, Srinivasa N. ;

Rice, Andrew S. C. ;

Rowbotham, Michael ;

Sena, Emily ;

Siddall, Philip ;

Smith, Blair H. ;

Wallace, Mark .

LANCET NEUROLOGY, 2015, 14 (02) :162-173

[10] The Evolution of Neuromodulation in the Treatment of Chronic Pain: Forward-Looking Perspectives [J].

Fishman, Michael A. ;

Antony, Ajay ;

Esposito, Michael ;

Deer, Timothy ;

Levy, Robert .

PAIN MEDICINE, 2019, 20 :S58-+

← 1 2 3 4 5 →