Evidence map›Paper›PMID 34363307›Full record

Trial reportPain practice : the official journal of World Institute of Pain2021

Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain.

Michael Fishman, Harold Cordner, Rafael Justiz, David Provenzano, Christopher Merrell, Binit Shah, Julian Naranjo, Philip Kim, Aaron Calodney, Jonathan Carlson and 4 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Pain practice : the official journal of World Institute of Pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
21.9field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 120 citations in OpenAlex.

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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

14 authors at 11 institutions in 1 country.

Michael FishmanCenter for Interventional Pain and Spine, Exton, Pennsylvania, USA.
Harold CordnerFlorida Pain Management Associates, Sebastian, Florida, USA.
Rafael JustizOklahoma Pain Physicians, Oklahoma City, Oklahoma, USA.
David ProvenzanoPain Diagnostics and Interventional Care, LLC, Sewickly, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-2147-3523
Christopher MerrellCoastal Carolina Research Center, Charleston, South Carolina, USA.
Binit ShahCarolinas Research Institute, PLLC, Huntersville, North Carolina, USA.
Julian NaranjoSouth Florida Clinical Research, South Miami, Florida, USA.
Philip KimCenter for Interventional Pain and Spine, Exton, Pennsylvania, USA.
Aaron CalodneyPrecision Spine Care, Tyler, Texas, USA.
Jonathan CarlsonHawaii Pain and Spine, Kailua, Hawaii, USA.
Richard BundschuCoastal Orthopedics, Bradenton, Florida, USA.
Mahendra SanapatiGlobal Scientific Innovations, LLC, Evansville, Illinois, USA.
Vipul MangalNational Spine and Pain Center, Oxon Hill, Maryland, USA.
Ricardo VallejoNational Spine and Pain Centers, Bloomington, Illinois, USA.ORCID https://orcid.org/0000-0002-3568-7151
International Spine, Pain & Performance · USCarolina BioOncology Institute · USClinical Research of South Florida · USCoastal Carolina University · USCoastal Orthopedics · USFlorida Urology Associates · USOcean Era (United States) · USOklahoma Department of Rehabilitation Services · USPain Management Institute · USPrecision Spine (United States) · USUniversity of Evansville · US

Funding

Stimgenics
6 · The paper itself

Abstract

backgroundSpinal cord stimulation (SCS) is a well-established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain-related behavior and pain-relevant biological processes.

objectiveThe purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP).

methodsThis prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12-month follow-up.

resultsOne hundred twenty-eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3-month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups.

conclusionSuperiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were sustained over 12 months and are expected to significantly impact the management of chronic LBP.

Indexed as

Chronic PainSpinal Cord StimulationBack PainHumansLegProspective StudiesSpinal CordTreatment Outcomeback paindifferential target multiplexedrandomized controlled trialspinal cord stimulation

Identifiers

PMID34363307
PMCPMC9290817
OpenAlexW3191471449

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.