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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.
Qual Life Res. 2018 08; 27(8):2035-2044.QL

Abstract

PURPOSE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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).

Authors+Show Affiliations

IPM Medical Group, Inc., Walnut Creek, CA, USA.Swedish Pain Center, Seattle, WA, USA.The Pain Center of Arizona and HOPE Research Institute, Phoenix, AZ, USA.Clinical Affairs, Nevro Corp., 1800 Bridge Parkway, Redwood City, CA, 94065, USA.Pain Specialists of Oregon, Eugene, OR, USA.Center for Clinical Research and Carolina's Pain Institute at Brookstown, Wake Forest Baptist Health, Winston-Salem, NC, USA.Millennium Pain Center, Bloomington, IL, USA.Advanced Pain Therapy, PLLC, Hattiesburg, MS, USA.Comprehensive Pain and Rehabilitation, Pascagoula, MS, USA.Coastal Orthopedics and Pain Medicine, Bradenton, FL, USA.Swedish Pain Center, Seattle, WA, USA.Millennium Pain Center, Bloomington, IL, USA.The Pain Center of Arizona and HOPE Research Institute, Phoenix, AZ, USA.Clinical Affairs, Nevro Corp., 1800 Bridge Parkway, Redwood City, CA, 94065, USA.Clinical Affairs, Nevro Corp., 1800 Bridge Parkway, Redwood City, CA, 94065, USA.Clinical Affairs, Nevro Corp., 1800 Bridge Parkway, Redwood City, CA, 94065, USA. jey.subbaroyan@nevro.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29858746

Citation

Amirdelfan, Kasra, et al. "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." Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, vol. 27, no. 8, 2018, pp. 2035-2044.
Amirdelfan K, Yu C, Doust MW, et al. 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. Qual Life Res. 2018;27(8):2035-2044.
Amirdelfan, K., Yu, C., Doust, M. W., Gliner, B. E., Morgan, D. M., Kapural, L., Vallejo, R., Sitzman, B. T., Yearwood, T. L., Bundschu, R., Yang, T., Benyamin, R., Burgher, A. H., Brooks, E. S., Powell, A. A., & Subbaroyan, J. (2018). 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. Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 27(8), 2035-2044. https://doi.org/10.1007/s11136-018-1890-8
Amirdelfan K, et al. 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. Qual Life Res. 2018;27(8):2035-2044. PubMed PMID: 29858746.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Amirdelfan,Kasra, AU - Yu,Cong, AU - Doust,Matthew W, AU - Gliner,Bradford E, AU - Morgan,Donna M, AU - Kapural,Leonardo, AU - Vallejo,Ricardo, AU - Sitzman,B Todd, AU - Yearwood,Thomas L, AU - Bundschu,Richard, AU - Yang,Thomas, AU - Benyamin,Ramsin, AU - Burgher,Abram H, AU - Brooks,Elizabeth S, AU - Powell,Ashley A, AU - Subbaroyan,Jeyakumar, Y1 - 2018/06/01/ PY - 2018/05/22/accepted PY - 2018/6/3/pubmed PY - 2019/9/19/medline PY - 2018/6/3/entrez KW - 10 kHz KW - Chronic low-back pain KW - High-frequency SCS KW - Leg pain KW - Neuropathic pain KW - Quality of life KW - Spinal cord stimulation SP - 2035 EP - 2044 JF - Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation JO - Qual Life Res VL - 27 IS - 8 N2 - PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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). SN - 1573-2649 UR - https://www.unboundmedicine.com/medline/citation/29858746/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_ L2 - https://doi.org/10.1007/s11136-018-1890-8 DB - PRIME DP - Unbound Medicine ER -