Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months

Abstract Introduction Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. There is evidence demonstrating high frequency 10kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with Failed Back Surgery Syndrome (FBSS) but there is limited evidence in CNLBP without prior surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10kHz SCS for this population. Methods This is a multicentre double-blind randomised sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10kHz SCS plus usual care (intervention group) or sham 10kHz SCS plus usual care (control group) after full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. Primary outcome will be a 7 day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6-months adjusting for baseline outcome scores. Incremental cost per quality adjusted life year (QALY) will be calculated at 6-months and over the patient lifetime. Discussion The outcomes of this trial will inform clinical practice and healthcare policy on the role of high frequency 10kHz SCS for patients with CNLBP without prior surgery.

Download Full-text

Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol

Trials ◽

10.1186/s13063-019-3831-4 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 6

Author(s):

Adnan Al-Kaisy ◽

Jonathan Royds ◽

Stefano Palmisani ◽

David Pang ◽

Samuel Wesley ◽

...

Keyword(s):

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Controlled Trial ◽

Trial Protocol ◽

Low Back ◽

Double Blind

Download Full-text

Spinal Cord Stimulation: Comparing Traditional Low-frequency Tonic Waveforms to Novel High Frequency and Burst Stimulation for the Treatment of Chronic Low Back Pain

Current Pain and Headache Reports ◽

10.1007/s11916-019-0763-3 ◽

2019 ◽

Vol 23 (4) ◽

Cited By ~ 9

Author(s):

Ariel Morales ◽

R. Jason Yong ◽

Alan D. Kaye ◽

Richard D. Urman

Keyword(s):

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Low Frequency ◽

Low Back ◽

Burst Stimulation

Download Full-text

High-frequency spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain—single-center experience

Neurosurgical Review ◽

10.1007/s10143-020-01462-5 ◽

2021 ◽

Author(s):

Stefan Motov ◽

Kaywan Aftahy ◽

Ann-Kathrin Jörger ◽

Arthur Wagner ◽

Bernhard Meyer ◽

...

Keyword(s):

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Failed Back Surgery Syndrome ◽

Low Back ◽

Vas Score ◽

Failed Back Surgery ◽

Back Surgery

AbstractTreatment of patients with failed back surgery syndrome (FBSS) with predominant low back pain (LBP) remains challenging. High-frequency spinal cord stimulation (HF10 SCS) is believed to achieve significant pain reduction. We aimed to evaluate the real-life efficacy of HF-10 SCS in a tertiary spine center. A prospective observational study of all patients with FBSS and predominant LBP who underwent HF-10 SCS surgery was performed between 2016 and 2018. Patients > 18 years with Visual Analogue Scale (VAS) scores of ≥ 5 for LBP and pain duration > 6 months under stable medication were implanted percutaneous under general anesthesia and a trial phase of 7–14 days was accomplished. Primary end point was a successful trial defined as ≥ 50% VAS score reduction for LBP. Thirty-four of 39 (85%) subjects had a successful trial. Fifty-three percent were female and the mean age was 69 years. Median follow-up lasted for 10 months. Devices were removed after a median of 10 months in 5 cases. Remaining 29 patients stated significant VAS score reduction for LBP from 8.1 to 2.9 and VAS for leg pain from 4.9 to 2.2. Twenty-four percent of all patients were able to discontinue their opioids. Eight of 9 patients (89%) with signs of adjacent disc disease and 7 of 10 (70%) patients with hardware failure were successfully implanted with significant VAS reduction for LBP. HF-10 SCS achieves significant pain reduction in most patients with FBSS and predominant LBP. It might be an efficient alternative to revision surgery.

Download Full-text

Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (MODULATE-LBP): A Trial Protocol

10.21203/rs.2.12200/v2 ◽

2019 ◽

Author(s):

Adnan Al-Kaisy ◽

Jonathan Royds ◽

Stefano Palmisani ◽

David Pang ◽

Samuel Wesley ◽

...

Keyword(s):

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Controlled Trial ◽

Low Back ◽

Double Blind ◽

Prior Surgery ◽

Secondary Outcomes

Abstract Introduction Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. There is evidence demonstrating high frequency 10kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with Failed Back Surgery Syndrome (FBSS) but there is limited evidence in CNLBP without prior surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10kHz SCS for this population. Methods This is a multicentre double-blind randomised sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10kHz SCS plus usual care (intervention group) or sham 10kHz SCS plus usual care (control group) after full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. Primary outcome will be a 7 day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6-months adjusting for baseline outcome scores. Incremental cost per quality adjusted life year (QALY) will be calculated at 6-months and over the patient lifetime. Discussion The outcomes of this trial will inform clinical practice and healthcare policy on the role of high frequency 10kHz SCS for patients with CNLBP without prior surgery.

Download Full-text

Comparison of Spinal Cord Stimulation Waveforms for Treating Chronic Low Back Pain: Systematic Review and Meta-Analysis

January 2018 - Pain Physician ◽

10.36076/ppj.2020/23/451 ◽

2020 ◽

Vol 5;23 (9;5) ◽

pp. 451-460

Author(s):

Alaa Abd-Elsayed

Keyword(s):

Systematic Review ◽

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Meta Analysis ◽

Low Back ◽

Prospective Cohort Studies ◽

Tonic Stimulation

Background: The treatment of chronic refractory low back pain (LBP) is challenging. Conservative and pharmacologic options have demonstrated limited efficacy. Spinal cord stimulation (SCS) has been shown to be effective in reducing chronic LBP in various contexts. With emerging SCS technologies, the collective evidence of novel waveforms relative to traditional tonic stimulation for treating chronic LBP has yet to be clearly characterized. Objectives: To provide evidence for various SCS waveforms—tonic, burst, and high frequency (HF)—relative to each other for treating chronic LBP. Study Design: Systematic review and meta-analysis. Methods: PubMed, Medline, Cochrane Library, prior systematic reviews, and reference lists were screened by 2 separate authors for all randomized trials and prospective cohort studies comparing different SCS waveforms for treatment of chronic LBP. Results: We identified 11 studies that included waveform comparisons for treating chronic LBP. Of these, 6 studies compared burst versus tonic, 2 studies compared burst versus HF, and 3 studies compared tonic versus HF. A meta-analysis of 5 studies comparing burst versus tonic was conducted and revealed pooled superiority of burst over tonic in pain reduction. One study comparing burst versus tonic was excluded given technical challenges in data extraction. Limitations: Both randomized controlled trials and prospective cohort studies were included for meta-analysis. Several studies included a high risk of bias in at least one domain. Conclusions: Burst stimulation is superior to tonic stimulation for treating chronic LBP. However, superiority among other waveforms has yet to be clearly established given some heterogeneity and limitations in evidence. Given the relative novelty of burst and HF SCS waveforms, evidence of longitudinal efficacy is needed. Key words: Chronic low back pain, spinal cord stimulation, tonic, burst, high frequency

Download Full-text