Evidence map›Paper›PMID 35365190›Full record

ArticleTrials2022

The effect of extracorporeal shock wave therapy in acute traumatic spinal cord injury on motor and sensory function within 6 months post-injury: a study protocol for a two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled clinical trial.

Iris Leister, Rainer Mittermayr, Georg Mattiassich, Ludwig Aigner, Thomas Haider, Lukas Machegger, Harald Kindermann, Anja Grazer-Horacek, Johannes Holfeld, Wolfgang Schaden

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04474106 (The Effect of Extracorporeal Shock Wave Therapy), 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
2.6field-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.

NCT04474106 narecruitingnot on this map

The Effect of Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury: A Two-arm Three-stage Adaptive, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial

TypeinterventionalSponsorAUVARan2020 to 2026Enrolled246ConditionsAcute Traumatic Spinal Cord InjuryArmsShock waves, dummy head
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Immediate administration of hTERT-MSCs-IDO1-EVs reduces hypoalbuminemia after spinal cord injury.Veterinary research forum : an international quarterly journal · 2024
    Article
  11. Spinal cord injury: molecular mechanisms and therapeutic interventions.Signal transduction and targeted therapy · 2023
    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

10 authors at 6 institutions in 2 countries.

Iris Leister *ParaMove, SCI Research Unit, BG Trauma Center Murnau, Murnau, Germany, and Paracelus Medical University, Salzburg, Austria. iris.leister@bgu-murnau.de.ORCID http://orcid.org/0000-0002-5963-0598
Rainer Mittermayr *Ludwig-Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.
Georg MattiassichLudwig-Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.
Ludwig AignerParaMove, SCI Research Unit, BG Trauma Center Murnau, Murnau, Germany, and Paracelus Medical University, Salzburg, Austria.
Thomas HaiderDepartment of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.
Lukas MacheggerDivision of Neuroradiology, Christian Doppler Medical Center, Paracelsus Medical University, Salzburg, Austria.
Harald KindermannDepartment of Marketing and Electronic Business, University of Applied Sciences Upper Austria, Steyr, Austria.
Anja Grazer-HoracekAUVA Rehabilitation Clinic Tobelbad, Tobelbad, Austria.
Johannes HolfeldUniversity Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Wolfgang SchadenLudwig-Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.
Paracelsus Medical University · ATUnfallkrankenhaus Meidling · ATInnsbruck Medical University · ATLudwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with AUVA · ATMedical University of Vienna · ATUniversity of Applied Sciences Upper Austria · AT

Funding

Allgemeine Unfallversicherungsanstalt NA
6 · The paper itself

Abstract

backgroundThe pathological mechanism in acute spinal cord injury (SCI) is dual sequential: the primary mechanical lesion and the secondary injury due to a cascade of biochemical and pathological changes initiated by the primary lesion. Therapeutic approaches have focused on modulating the mechanisms of secondary injury. Despite extensive efforts in the treatment of SCI, there is yet no causal, curative treatment approach available. Extracorporeal shock wave therapy (ESWT) has been successfully implemented in clinical use. Biological responses to therapeutic shock waves include altered metabolic activity of various cell types due to direct and indirect mechanotransduction leading to improved migration, proliferation, chemotaxis, modulation of the inflammatory response, angiogenesis, and neovascularization, thus inducing rather a regeneration than repair. The aim of this clinical study is to investigate the effect of ESWT in humans within the first 48 h after an acute traumatic SCI, with the objective to intervene in the secondary injury phase in order to reduce the extent of neuronal loss.

methodsThis two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled study has been initiated in July 2020, and a total of 82 patients with acute traumatic SCI will be recruited for the first stage in 15 participating hospitals as part of a two-armed three-stage adaptive trial design. The focused ESWT (energy flux density: 0.1-0.19 mJ/mm DISCUSSION: The application of ESWT activates the nervous tissue regeneration involving a multitude of various biochemical and cellular events and leads to a decreased neuronal loss. ESWT might contribute to an improvement in the treatment of acute traumatic SCI in future clinical use.

trial registrationClinicalTrials.gov NCT04474106.

Indexed as

Extracorporeal Shockwave TherapySpinal Cord InjuriesAdaptive Clinical Trials as TopicDouble-Blind MethodHumansMechanotransduction, CellularMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicSensationExtracorporeal shock wave therapyOff-label useSpinal cord injuriesTreatment outcome

Identifiers

PMID35365190
PMCPMC8973563
OpenAlexW4221015941

What OpenQuestion holds

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LicenceCC BY
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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.