Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort

Thomson, Simon; Chawla, Rajiv; Love‐Jones, Sarah; Sharma, Manohar; Vajramani, Girish; Williams, Adam; Eldabe, Sam; Bhagat, Shaishav; Patel, Nik; Hazelgrove, J

doi:10.1007/s40122-021-00307-3

Cited by 14 publications

(14 citation statements)

References 25 publications

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“…Subjects also reported clinically significant reductions in patient-centric outcomes of disability (ODI), pain interference (BPI-9), and PGIC. Thomson et al, 2021 538 Post-market prospective clinical follow-up 42 I-B NRS, ODI, EQ-5D-5L Among the 37 patients completing 2-year follow-up, NRS pain scores improved from 7.0 ± to 3.5 ± 0.3, ODI scores improved from 46.2 ± 2.2 to 29.2 ± 3.1, and health-related quality of life improved from 0.426 ± 0.035 to 0.675 ± 0.030. Additionally, 57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements.…”

Section: Neuromodulationmentioning

confidence: 99%

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

Sayed¹,

Grider²,

Strand³

et al. 2022

JPR

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Introduction Painful lumbar spinal disorders represent a leading cause of disability in the US and worldwide. Interventional treatments for lumbar disorders are an effective treatment for the pain and disability from low back pain. Although many established and emerging interventional procedures are currently available, there exists a need for a defined guideline for their appropriateness, effectiveness, and safety. Objective The ASPN Back Guideline was developed to provide clinicians the most comprehensive review of interventional treatments for lower back disorders. Clinicians should utilize the ASPN Back Guideline to evaluate the quality of the literature, safety, and efficacy of interventional treatments for lower back disorders. Methods The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations. Experts from the fields of Anesthesiology, Physiatry, Neurology, Neurosurgery, Radiology, and Pain Psychology developed the ASPN Back Guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for back-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using United States Preventive Services Task Force (USPSTF) criteria and consensus points are presented. Results After a comprehensive review and analysis of the available evidence, the ASPN Back Guideline group was able to rate the literature and provide therapy grades to each of the most commonly available interventional treatments for low back pain. Conclusion The ASPN Back Guideline represents the first comprehensive analysis and grading of the existing and emerging interventional treatments available for low back pain. This will be a living document which will be periodically updated to the current standard of care based on the available evidence within peer-reviewed literature.

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Section: Neuromodulationmentioning

confidence: 99%

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

Sayed¹,

Grider²,

Strand³

et al. 2022

JPR

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“…Percutaneous PNS of the LMBN is a relatively new modality, and to date, there are 10 human, clinical studies focusing on nonspinal neuromodulation for chronic axial LBP (16)(17)(18)(19)(20)(21)(22)(23)(24)(25). Kapural et al (25) was the first to publish clinical data using the SPRINT device.…”

Section: Discussionmentioning

confidence: 99%

“…However, deeper analysis of the data shows that though the primary outcome was not significant, the actual values of functional outcome measures were significantly improved at 120 days for the treatment group compared to the sham in ODI (difference −5.4 95% CI −9.5 to −1.2, p = 0.011) and EQ-5D (Difference 0.071 95% CI 0.018 to 0.123, p = 0.009) respectively, though VAS trended toward significance (Difference −0.9, 95% CI −1.6 to −0.1, p = 0.032) ( 19 ). Next, Thomson et al ( 16 ) investigated NRS, ODI, and EQ-5D changes on 37 patients for 2 years. They found that at 2 years all outcome measures had significantly improved from baseline ( p < 0.001) ( 16 ).…”

Section: Discussionmentioning

confidence: 99%

“…Next, Thomson et al ( 16 ) investigated NRS, ODI, and EQ-5D changes on 37 patients for 2 years. They found that at 2 years all outcome measures had significantly improved from baseline ( p < 0.001) ( 16 ). This study design was a prospective, multicenter, longitudinal cohort, and although it is not level 1 evidence, it addresses most causes of bias and presents long-term data, but in a rather small sample size.…”

Section: Discussionmentioning

confidence: 99%

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Non-Spinal Neuromodulation of the Lumbar Medial Branch Nerve for Chronic Axial Low Back Pain: A Narrative Review

et al. 2022

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Chronic low back pain remains highly prevalent, costly, and the leading cause of disability worldwide. Symptoms are complex and treatment involves an interdisciplinary approach. Due to diverse anatomical etiologies, treatment outcomes with interventional options are highly variable. A novel approach to treating chronic axial low back pain entails the use of peripheral nerve stimulation to the lumbar medial branch nerve, and this review examines the clinical data of the two different, commercially available, non-spinal neuromodulation systems. This review provides the clinician a succinct narrative that presents up-to-date data objectively. Our review found ten clinical studies, including one report of two cases, six prospective studies, and three randomized clinical trials published to date. Currently, there are different proposed mechanisms of action to address chronic axial low back pain with different implantation techniques. Evidence suggests that peripheral nerve stimulation of the lumbar medial branch nerve may be effective in improving pain and function in patients with chronic axial low back pain symptoms at short and long term follow up, with good safety profiles. Further long-term data is needed to consider this intervention earlier in the pain treatment algorithm, but initial data are promising.

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“…The safety profile over the initial 2-year period has been published previously. 15 The late term safety profile contains 1 related event (Table 3). This cohort reports no device related serious adverse events.…”

Section: Safety Outcomesmentioning

confidence: 99%

Restorative neurostimulation for chronic mechanical low back pain – Three year results from the United Kingdom post market clinical follow-up registry

Thomson

Williams

Vajramani

et al. 2023

British Journal of Pain

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Introduction Mechanical chronic low back pain is often associated with impaired neuromuscular control of the lumbar multifidus muscles, the most important stabilizers of the lumbar spine. Restorative neurostimulation is a modality for the treatment for this specific subset of patients aimed to facilitate restoration of neuromuscular control by bilateral stimulation of the L2 medial branches. Evidence from both prospective and randomised clinical trials to date has demonstrated substantial improvements in clinical outcomes such as pain, disability and health-related quality of life. Methods This study is an open label prospective follow-up for the treatment of chronic mechanical low back pain of nociceptive origin with restorative neurostimulation. Patients completed assessments for pain, disability and health-related quality of life. Outcomes were collected at 45, 90 and 180 days, and 1, 2 and 3 years after the activation visit. Results Forty-two patients were implanted with the device and 33 (79%) were available at the 3-year appointment. Patients in this cohort presented with severe chronic low back pain (NRS = 7.0 ± 0.2) and severe disability (ODI 46.6 ± 12.0). The health-related quality of life was also severely impacted at baseline (EQ-5D 0.426 ± 0.061). Changes in pain, disability and quality of life at three-year follow-up demonstrated a statistically significant improvement between baseline and 1, 2 and 3 years. After 3 years of therapy, average NRS scores had reduced to 2.7± 0.3 and mean ODI score to 26.0 ± 3.1 while EQ-5D-5L index improved to 0.707 ± 0.036. Conclusions The ongoing follow-up of this post market cohort continues to demonstrate that restorative neurostimulation provides a statistically significant, clinically meaningful and durable response across pain, disability and quality-of life scores for patients suffering chronic mechanical low back pain that has been refractory to conventional management. Trial Registration ClinicalTrials.gov Identifier: NCT01985230.

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Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort

Cited by 14 publications

References 25 publications

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

Non-Spinal Neuromodulation of the Lumbar Medial Branch Nerve for Chronic Axial Low Back Pain: A Narrative Review

Restorative neurostimulation for chronic mechanical low back pain – Three year results from the United Kingdom post market clinical follow-up registry

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