Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

被引：63

作者：

Amirdelfan, Kasra ^{[1
]}

Yu, Cong ^{[2
]}

Doust, Matthew W. ^{[3
,4
]}

Gliner, Bradford E. ^{[5
]}

Morgan, Donna M. ^{[6
]}

Kapural, Leonardo ^{[7
,8
]}

Vallejo, Ricardo ^{[9
]}

Sitzman, B. Todd ^{[10
]}

Yearwood, Thomas L. ^{[11
]}

Bundschu, Richard ^{[12
]}

Yang, Thomas ^{[2
]}

Benyamin, Ramsin ^{[9
]}

Burgher, Abram H. ^{[3
,4
]}

Brooks, Elizabeth S. ^{[5
]}

Powell, Ashley A. ^{[5
]}

Subbaroyan, Jeyakumar ^{[5
]}

机构：

[1] IPM Med Grp Inc, Walnut Creek, CA USA

[2] Swedish Pain Ctr, Seattle, WA USA

[3] Pain Ctr Arizona, Phoenix, AZ USA

[4] HOPE Res Inst, Phoenix, AZ USA

[5] Nevro Corp, Clin Affairs, 1800 Bridge Pkwy, Redwood City, CA 94065 USA

[6] Pain Specialists Oregon, Eugene, OR USA

[7] Wake Forest Baptist Hlth, Clin Res Ctr, Winston Salem, NC USA

[8] Wake Forest Baptist Hlth, Carolinas Pain Inst Brookstown, Winston Salem, NC USA

[9] Millennium Pain Ctr, Bloomington, IL USA

[10] Adv Pain Therapy PLLC, Hattiesburg, MS USA

[11] Comprehens Pain & Rehabil, Pascagoula, MS USA

[12] Coastal Orthoped & Pain Med, Bradenton, FL USA

来源：

QUALITY OF LIFE RESEARCH | 2018年 / 27卷 / 08期

关键词：

Spinal cord stimulation; Quality of life; Neuropathic pain; 10; kHz; High-frequency SCS; Chronic low-back pain; Leg pain; RANDOMIZED CONTROLLED MULTICENTER; CONVENTIONAL MEDICAL-MANAGEMENT; CLINICALLY IMPORTANT DIFFERENCE; REFRACTORY ANGINA-PECTORIS; 10-KHZ HIGH-FREQUENCY; FORM HEALTH SURVEY; NEUROPATHIC PAIN; GLOBAL BURDEN; FOLLOW-UP; DISABILITY;

D O I：

10.1007/s11136-018-1890-8

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Chronic axial low-back pain is a debilitating disorder that impacts all aspects of an afflicted individual's life. Effective, durable treatments have historically been elusive. Interventional therapies, such as spinal cord stimulation (SCS), have shown limited efficacy at best. Recently, a novel treatment, 10 kHz SCS, has demonstrated superior pain relief compared with traditional SCS in a randomized controlled trial (RCT). In this manuscript, we report on the long-term improvements in quality of life (QoL) outcomes for subjects enrolled in this study. A prospective, multicenter, randomized controlled trial (SENZA-RCT) was conducted. Patients with both chronic back and leg pain were enrolled and randomized (1:1) into 10 kHz SCS or traditional SCS treatment groups. A total of 171 subjects received a permanent SCS device implant. QoL and functionality measures were collected up to 12 months. The device remote control utilization, which is an indication of patient interaction with the device for adjustments, was collected at 24-month post-implantation. At 12 months, a higher proportion of 10 kHz SCS subjects had marked improvement of their disability (Oswestry Disability Index) to a "moderate" or "minimal" impact on their daily function versus the control group. The subjects also reported better improvement in the Global Assessment of Functioning, Clinician Global Impression of Change, Pittsburgh Sleep Quality Index, and short-form McGill Pain Questionnaire, compared to traditional SCS subjects. The 10 kHz SCS subjects also reported far higher rates of both driving and sleeping with their device turned on, as well as reduced reliance on their programmers to adjust therapy settings. In addition to superior pain relief, 10 kHz SCS provides long-term improvements in quality of life and functionality for subjects with chronic low-back and leg pain. Trial registration: ClinicalTrials.gov (NCT01609972).

引用

页码：2035 / 2044

页数：10

共 51 条

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