Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study.

Published on Apr 1, 2021in Neuromodulation4.722
· DOI :10.1111/NER.13324
John A. Hatheway2
Estimated H-index: 2
,
Vipul Mangal1
Estimated H-index: 1
+ 17 AuthorsMatthew T. Kelly1
Estimated H-index: 1
Sources
Abstract
Background and objectives Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach. Materials and methods Vectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction. Results There was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit. Conclusions Long-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow. Clinical trial registration The Clinicaltrials.gov registration number for the study is NCT03345472.
References32
Newest
#1Lisa Goudman (Vrije Universiteit Brussel)H-Index: 10
#2Alessandra BruzzoH-Index: 1
Last. Maarten Moens (Vrije Universiteit Brussel)H-Index: 17
view all 4 authors...
INTRODUCTION: Due to the difficulties encountered in the treatment process of patients with chronic pain, it is of utmost importance to involve patients themselves in their rehabilitation trajectory. Patient engagement can be obtained by motivating patients to select their own treatment goals. We hypothesize that applying goal setting, as a form of patient empowerment, in potential candidates for spinal cord stimulation (SCS) may further improve the outcome of SCS. As a first step in creating pa...
Source
#1James NorthH-Index: 11
#2Eric LoudermilkH-Index: 1
Last. Roshini JainH-Index: 6
view all 23 authors...
OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperceptio...
Source
#1Ramsin M BenyaminH-Index: 58
#2GalanH-Index: 1
Last. David A. ProvenzanoH-Index: 20
view all 11 authors...
BACKGROUND: Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome. OBJECTIVES: The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters. STUDY DESIGN: This was a prospective cohort study. SETTING: This study took place at 11 centers in North America. METHODS: Forty-four SCS-naive patients underwent...
Source
#1Tanja E Hamm-Faber (Albert Schweitzer Hospital)H-Index: 5
#2Ismail Gültuna (Albert Schweitzer Hospital)H-Index: 8
Last. Hans A. Aukes (Albert Schweitzer Hospital)H-Index: 5
view all 4 authors...
OBJECTIVES: To investigate the long-term effect of high-dose spinal cord stimulation (HD-SCS) in patients with chronic refractory low back and leg pain due to failed back surgery syndrome (FBSS). STUDY DESIGN: Prospective case series; pilot study. MATERIALS AND METHODS: Patients with chronic low back and leg pain (CBLP) due to failed back surgery syndrome (FBSS) were screened for SCS according to the Dutch Neuromodulation Society guidelines. Patients with a pain score of >50 (on a visual analogu...
Source
#1Lucy Gee (Albany Medical College)H-Index: 11
#2Heather Smith (Albany Medical College)H-Index: 10
Last. Julie G. Pilitsis (Albany Medical College)H-Index: 29
view all 8 authors...
BACKGROUND: Chronic pain causes a significant burden to the US health care system, is difficult to treat, and remains a significant contributor to increased opioid use in the United States. Spinal cord stimulation (SCS) has been FDA approved for the treatment of chronic pain. OBJECTIVE: To evaluate the hypothesis that SCS reduces opioid use, and alone maintains clinical outcome measures of pain and psychosocial determinants of health. METHODS: In this prospective cohort study, we evaluated 86 pa...
Source
#1Adnan Al-Kaisy (St Thomas' Hospital)H-Index: 20
#2Stefano Palmisani (St Thomas' Hospital)H-Index: 20
Last. Andrea TrescottH-Index: 1
view all 8 authors...
INTRODUCTION: The increasing use of high frequency paresthesia-free spinal cord stimulation has been associated with improved outcomes in the therapy of neuropathic pain. What is unknown is the effect of varying frequency on pain relief and the placebo effect. MATERIALS AND METHODS: This is a prospective, randomized, sham-controlled double blind crossover study. Subjects with predominantly axial low back pain undergoing spinal cord stimulation therapy for failed back surgery syndrome were random...
Source
#1Ashwini SharanH-Index: 63
#2Jonathan RileyH-Index: 22
Last. David A. ProvenzanoH-Index: 20
view all 8 authors...
Study Design: Observational study using insurance claims. Objective: To quantify opioid usage leading up to spinal cord stimulation (SCS) and the potential impact on outcomes of SCS. Setting: SCS is an interventional therapy that often follows opioid usage in the care continuum for chronic pain. Methods: This study identified SCS patients using the Truven Health MarketScan databases from January 2010 to December 2014. The index event was the first occurrence of a permanent SCS implant. Indicator...
Source
#1Simon Thomson (Basildon and Thurrock University Hospitals NHS Foundation Trust)H-Index: 12
#2Moein Tavakkolizadeh (UCLH: University College London Hospitals NHS Foundation Trust)H-Index: 1
Last. Michael A. MoffittH-Index: 9
view all 8 authors...
Objective The PROCO RCT is a multicenter, double-blind, crossover, randomized controlled trial (RCT) that investigated the effects of rate on analgesia in kilohertz frequency (1–10 kHz) spinal cord stimulation (SCS). Materials and Methods Patients were implanted with SCS systems and underwent an eight-week search to identify the best location (“sweet spot”) of stimulation at 10 kHz within the searched region (T8–T11). An electronic diary (e-diary) prompted patients for pain scores three times pe...
Source
#4Richard B. North (JHUSOM: Johns Hopkins University School of Medicine)H-Index: 46
Objective The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs. Methods Following a successful tonic trial, 100 subjects were randomized to receive one stimulation mode for the first 12 weeks, and then the other stimulation mode for the next 12 weeks. T...
Source
#1Nancy Devlin (University of Sheffield)H-Index: 53
#2Koonal ShahH-Index: 17
Last. Ben A. van Hout (University of Sheffield)H-Index: 29
view all 5 authors...
A new version of the EQ-5D, the EQ-5D-5L, is available. The aim of this study is to produce a value set to support use of EQ-5D-5L data in decision-making. The study design followed an international research protocol. Randomly selected members of the English general public completed 10 time trade-off and 7 discrete choice experiment tasks in face-to-face interviews. A 20-parameter hybrid model was used to combine time trade-off and discrete choice experiment data to generate values for the 3,125...
Source
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