Evidence map›Paper›PMID 34478115›Full record

ArticlePain and therapy2021

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

Simon Thomson, Rajiv Chawla, Sarah Love-Jones, Manohar Sharma, Girish Vajramani, Adam Williams, Sam Eldabe, ReActiv8 PMCF Investigators

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pain and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01985230 (Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01985230 nacompletednot on this map

Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain

TypeinterventionalSponsorMainstay MedicalRan2014 to 2024Enrolled96ConditionsChronic Low Back PainArmsReActiv8 Implantable Stimulation System implanted and activated.
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Restorative neurostimulation of the lumbar multifidus muscles improves mobility, strength, pain and disability in patients with mechanical chronic low back pain.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Article
  3. Real-world two-year durability of restorative neurostimulation for treatment of multifidus dysfunction in patients with chronic low back pain: an observational German cohort study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Observational
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  12. Healthcare resource utilization for chronic low back pain among high-utilizers.The spine journal : official journal of the North American Spine Society · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Simon ThomsonPain and Neuromodulation Centre, Mid and South Essex University Hospitals NHS, Essex, UK. Simon.Thomson@nhs.net.ORCID http://orcid.org/0000-0002-3027-9343
Rajiv ChawlaDepartment of Pain Medicine, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Sarah Love-JonesDepartment of Pain Medicine, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
Manohar SharmaDepartment of Pain Medicine, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Girish VajramaniDepartment of Neurosurgery, University Hospital Southampton, Southampton, UK.
Adam WilliamsDepartment of Pain Medicine, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
Sam EldabeDepartment of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
ReActiv8 PMCF Investigators
North Bristol NHS Trust · GBUniversity of Liverpool · GBJames Cook University Hospital · GBMid Essex Hospital Services NHS Trust · GBUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLow back pain impacts most people throughout the course of their lives and contributes significantly to the global burden of disease. In some patients, symptoms resolve with little intervention, while others are amenable to surgical intervention, some cases are intractable to current care paradigms. Restorative neurostimulation is an emerging therapy for chronic mechanical low back pain.

methodsWe conducted a prospective post-market follow-up of 42 patients treated for longstanding chronic mechanical low back pain with restorative neurostimulation. Patients were followed up at 45, 90, and 180 days and 1 and 2 years following activation of the device. Pain, disability, and health-related quality of life were recorded.

resultsAmong the 37 patients completing 2-year follow-up, numerical rating scale (NRS) pain scores improved from 7.0 ± 0.2 to 3.5 ± 0.3 (p < 0.001), Oswestry Disability Index (ODI) scores improved from 46.2 ± 2.2 to 29.2 ± 3.1 (p < 0.001), and health-related quality of life (measured by the EuroQol 5-Dimension 5-Level questionnaire-EQ-5D-5L) improved from 0.426 ± 0.035 to 0.675 ± 0.030 (p < 0.001). 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.

conclusionThis real-world sample of patients shows that restorative neurostimulation can provide substantial and durable benefit to a cohort of patients that have traditionally had few reliable treatment options. Our findings support the continued used of this therapy in well-selected patients.

trial registrationClinicalTrials.gov Identifier: NCT01985230.

Indexed as

Mechanical chronic low back painMultifidusReal-world evidenceRestorative neurostimulation

Identifiers

PMID34478115
PMCPMC8586272
OpenAlexW3197668682

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.