Evidence map›Paper›PMID 29587729›Full record

Trial reportBMC surgery2018

Comparing the efficacy of targeted spinal cord stimulation (SCS) of the dorsal root ganglion with conventional medical management (CMM) in patients with chronic post-surgical inguinal pain: the SMASHING trial.

Frederique M U Mol, Rudi M Roumen, Marc R Scheltinga

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02349659 (A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT02349659 naterminatednot on this map

A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention: SMASHING

TypeinterventionalSponsorMaxima Medical CenterRan2014 to 2017Enrolled18ConditionsChronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)ArmsImplantation with the commercially available Axium neurostimulator
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Dorsal Root Ganglion (DRG) and Chronic Pain.Anesthesiology and pain medicine · 2021
    Review
  2. Ilioinguinal Neuropathy.Current pain and headache reports · 2020
    Review
  3. 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

3 authors at 2 institutions in 1 country.

Frederique M U MolDepartment of Surgery, Maxima Medical Center, de Run 4600, PO Box 7777, 5500, MB, Veldhoven, The Netherlands. frederique.mol@mmc.nl.
Rudi M RoumenDepartment of Surgery, Maxima Medical Center, de Run 4600, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Marc R ScheltingaDepartment of Surgery, Maxima Medical Center, de Run 4600, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Radboud University Nijmegen · NLMáxima Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA significant number of patients who undergo a standard inguinal hernia repair or a Pfannenstiel incision develop chronic (> 3 months) post-surgical inguinal pain (PSIP) due to nerve entrapment. If medication or peripheral nerve blocks fail, surgery including neurectomies may offer relief. However, some patients do not respond to any of the currently available remedial treatment modalities. Targeted spinal cord stimulation (SCS) of the dorsal root ganglion (DRG) is a relatively new type of therapy that has a potential to significantly reduce chronic PSIP. The Axium® SCS System (Spinal Modulation Inc., NY, USA) has been shown to be safe and successful in small cohorts of PSIP patients. Aim of this study is to evaluate targeted spinal cord stimulation therapy in patients with PSIP.

methodsA prospective, multicentre, randomized controlled trial with optional one-way crossover will assess the efficacy of the Axium® SCS system for the treatment of PSIP. Seventy-eight patients with intractable PSIP following open hernia repair or Pfannenstiel incision who did not respond favorably to previous pain treatment regimens including a neurectomy will be randomized to either an Axium® SCS arm or a control arm receiving only conventional medical management (CMM). Primary outcome is the difference in percentage of subjects with ≥50% pain relief after 6 months using a Numerical Pain Rating Scale (NPRS). Data are collected using a daily pain/sleep diary and a number needed to treat (NNT) analysis is performed. Various secondary outcomes will be collected. DISCUSSION: Targeted SCS stimulation of the DRG using the Axium® SCS system will possibly offer significant pain reduction in patients with PSIP who are refractory to other treatment modalities.

trial registrationThe study protocol is registered at the NIH Clinical Trials Registry ( http://clinicaltrials.gov , ClinicalTrials.gov identifier: NCT02349659 ) on January 29, 2015.

Indexed as

Ganglia, SpinalChronic PainCross-Over StudiesGroinHumansPain MeasurementProspective StudiesResearch DesignSpinal Cord StimulationDorsal root ganglion (DRG)Post-surgical inguinal pain (PSIP)Spinal cord stimulation (SCS)

Identifiers

PMID29587729
PMCPMC5872506
OpenAlexW2804083943

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.