Evidence map›Paper›PMID 39812968›Full record

ArticlePain and therapy2025

Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction.

Frank Schwab, Nagy Mekhail, Kiran V Patel, Meredith Langhorst, Robert D Heros, Jonathan Gentile, Sherif Costandi, Gregory Moore, Christopher Gilmore, Smith Manion and 20 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04803214 (ReActiv8 Stimulation Therapy vs Optimal Medical Management), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04803214 nacompletednot on this map

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

TypeinterventionalSponsorMainstay MedicalRan2021 to 2026Enrolled203ConditionsChronic Low-back PainArmsReActiv8
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Impact of Intramuscular Electrical Stimulation on Multifidus Muscle Function in Chronic Low Back Pain: A Randomized Controlled Trial.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Trial
  3. Article
  4. 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
  5. Lumbar multifidus muscle morphology on MRI after restorative neurostimulation for chronic low back pain: a single centre case series using the Goutallier classification.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
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
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

30 authors.

Frank SchwabNorthwell Health Orthopaedic Institute at Lenox Hill, 130 East 77th Street, Black Hall 7th, 11th, and 12th Floors, New York, NY, 10075, USA. fschwab@northwell.edu.ORCID http://orcid.org/0000-0003-2307-3037
Nagy MekhailCleveland Clinic, Cleveland, OH, USA.
Kiran V PatelNorthwell Health Pain Medicine, Anesthesiology, New York, NY, USA.
Meredith LanghorstOrthoIndy Hospital, Indianapolis, IN, USA.
Robert D HerosSpinal Diagnostics, Tualatin, OR, USA.
Jonathan GentileIndiana Spine Group, Indianapolis, IN, USA.
Sherif CostandiCleveland Clinic, Cleveland, OH, USA.
Gregory MoorePacific Sports and Spine, Eugene, OR, USA.
Christopher GilmoreCenter for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA.
Smith ManionMidwest Anesthesia Associates, Merriam, KS, USA.
Krishnan ChakravarthyInnovative Pain Treatment Solutions, Temecula, CA, USA.
S Craig MeyerColumbia Orthopaedic Group, Columbia, MO, USA.
Justin V BundyAugusta-Aiken Orthopedic Specialists, Augusta, GA, USA.
Jordan L TateSouthern Pain and Spine, Jasper, GA, USA.
Rebecca SandersFreeman Institute for Pain Management, Joplin, MO, USA.
Sandeep VaidSummit Spine & Joint Centers, Savannah, GA, USA.
Oszkar SzentirmaiCleveland Clinic Florida, Port St. Lucie, FL, USA.
Johnathan GoreeDepartment of Anesthesiology, University of Arkansas Medical Sciences, Little Rock, AR, USA.
Vikas V PatelDepartment of Orthopedic Surgery, University of Colorado, Denver, CO, USA.
Jeff LehmenLehmen Spine Center, St. Louis, MO, USA.
Mehul J DesaiInternational Spine Pain & Performance Center, Washington, DC, USA.
Jason E PopeEvolve Restorative Center, Santa Rosa, CA, USA.
Anthony GiuffridaCantor Spine Center, Paley Orthopedic and Spine Institute, Fort Lauderdale, FL, USA.
Salim HayekDivision of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA.
Sohrab Singh VirkNorthwell Health, New Hyde Park, NY, USA.
Richard PaiciusSouthern California Spine and Sport, Newport Beach, CA, USA.
William R KlemmeUniformed Services University of the Health Sciences, Bethesda, MD, USA.
Robert LevyAnesthesia Pain Care Consultants, LLC, Tamarac, FL, USA.
Christopher GilliganRobert Wood Johnson University Hospital/Rutgers Medical School, New Brunswick, NJ, USA.
RESTORE investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMany interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mechanical CLBP resulting from multifidus dysfunction. In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year.

methodsRESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L]).

resultsA total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (-19.7 ± 1.4 vs. -2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (-3.6 ± 0.2 vs. -0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm.

conclusionThe RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. This demonstration of treatment superiority over OMM through 1 year is a significant milestone in addressing a major health burden and unmet clinical need.

trial registrationClinicalTrials.gov Identifier: NCT04803214.

Indexed as

Chronic low back painMultifidus dysfunctionNeuromuscular controlNociceptive painPeripheral nerve stimulationRestorative neurostimulation

Identifiers

PMID39812968
PMCPMC11751280

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.