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

Kasra Amirdelfan,B Todd Sitzman,Elizabeth S Brooks,Matthew W Doust,Richard Bundschu,Abram H Burgher,Bradford E Gliner,Ricardo Vallejo,Ashley A Powell,Ramsin Benyamin,Donna M Morgan,Cong Yu,Thomas Yang,Thomas L Yearwood,Jeyakumar Subbaroyan,Leonardo Kapural

doi:10.1007/s11136-018-1890-8

Abstract

PurposeChronic 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.MethodsA 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.ResultsAt 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.ConclusionsIn 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).

Highlights

For the past two decades, low-back pain has been the single leading cause of disability worldwide, affecting 9.2% of the population [1, 2]
At 12 months, there was a notable improvement for the 10 kHz spinal cord stimulation (SCS) group compared with traditional SCS subjects in both average raw scores and distribution of subjects among the subcategories (p = .010, exact non-parametric Mann–Whitney test, 2-sided) (Fig. 1)
Within the 10 kHz SCS group, 69.6% of subjects had an improved Oswestry Disability Index (ODI) score sufficient to reclassify them into a lower disability category, whereas 55.1% of traditional SCS subjects were in a lower disability grouping at 12 months (Table 1)

Summary

Introduction

For the past two decades, low-back pain has been the single leading cause of disability worldwide, affecting 9.2% of the population [1, 2]. Intractable back pain dramatically affects one’s work function, activities of daily living, as well as social relationships with friends and family members. The global pervasiveness and intractable nature of this ailment, as the leading cause of disability in the population, results in tremendous healthcare utilization [3,4,5] and loss of workforce productivity [6, 7]. There is great need for improved treatment options for patients living with chronic low-back and leg pain, in order to reduce their pain, but to improve their quality of life (QoL)

Methods

Results

Conclusion