Evidence map›Paper›PMID 19945354›Full record

Trial reportThe journal of pain2010

A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment.

Barbara Rakel, Nicholas Cooper, Heather J Adams, Bryan R Messer, Laura A Frey Law, Douglas R Dannen, Carrie A Miller, Anya C Polehna, Rachelle C Ruggle, Carol G T Vance and 2 more

5 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of pain, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 61 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 8 pooled it
3.4field-weighted citation impact, top 8% 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.

NCT01888640 nacompletednot on this mapstarted 2013, after this paper: background citation

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

TypeinterventionalSponsorKathleen SlukaRan2013 to 2018Enrolled301ConditionsFibromyalgiaArmsTENS
NCT02592642 nacompletednot on this mapstarted 2014, after this paper: background citation

Self-Management to Improve Walking Ability in Degenerative Lumbar Spinal Stenosis: the Evaluation of Four Novel Strategies.

TypeinterventionalSponsorMount Sinai Hospital, CanadaRan2014 to 2017Enrolled104ConditionsDegenerative Lumbar Spinal StenosisArmsSelf-management Program, Workbook, Video, Pedometer, Instructional Workbook, Video, and Pedometer, Para-spinal TENS, Para-spinal Placebo TENS, Prototype Spinal Stenosis Belt
NCT03531541 nacompletednot on this mapstarted 2018, after this paper: background citation

Transcutaneous Electrical Nerve Stimulation and Cervical Joint Manipulation on Pressure Pain Threshold

TypeinterventionalSponsorUniversidade Federal de Sao CarlosRan2018 to 2019Enrolled144ConditionsPainArmsApplication of TENS, CJM, Placebo TENS, Placebo CJM
NCT03615469 naterminatednot on this mapstarted 2018, after this paper: background citation

Building Strength Through Rehabilitation for Heart Failure Patients

TypeinterventionalSponsorIndiana UniversityRan2018 to 2020Enrolled15ConditionsHeart FailureArmsTranscutaneous electrical stimulation, Neuromuscular electrical stimulation
NCT05955430 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Efficacy of Percutaneous Electrical Stimulation Compared to Transcutaneous Electrical Stimulation in Combination With an Education and Exercise Program in Patients With Knee Osteoarthritis

TypeinterventionalSponsorJosue Fernandez CarneroRan2023 to 2024Enrolled30ConditionsKnee OsteoarthritisArmsTherapeutic exercise, Pain education, Percutaneous electrical stimulation, Transcutaneous electrical stimulation, Placebo stimulation
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 8 syntheses or guidelines pooled it, 131 citations in OpenAlex.

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  8. Transcutaneous electrical nerve stimulation for acute pain.The Cochrane database of systematic reviews · 2015
    Pooled it
  9. Trial
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  13. Noninvasive neuromodulation reduces symptoms of restless legs syndrome.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021
    Trial
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1 more citing papers are in PubMed but not listed here.

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

12 authors at 2 institutions in 2 countries.

Barbara RakelUniversity of Iowa, College of Nursing, Iowa City, Iowa. Barbara-rakel@uiowa.edu
Nicholas Cooper
Heather J Adams
Bryan R Messer
Laura A Frey Law
Douglas R Dannen
Carrie A Miller
Anya C Polehna
Rachelle C Ruggle
Carol G T Vance
Deirdre M Walsh
Kathleen A Sluka
University of Iowa · USUniversity of Ulster · GB

Funding

Genetic and Trait Influences on Pain HeterogeneityK01AR056134 · NIAMS · UNIVERSITY OF IOWA · PI FREY LAW, LAURA A · 2009 to 2013
$587k
Effect of TENS on Knee Osteoarthritis Pain, Hyperalgesia, and FunctionR03NR010405 · NINR · UNIVERSITY OF IOWA · PI RAKEL, BARBARA · 2007 to 2008
$144k
NIAMS NIH HHS K01 AR056134NINR NIH HHS R03 NR010405
6 · The paper itself

Abstract

unlabelledThis study compared a new transient sham transcutaneous electrical nerve stimulation (TENS) that delivers current for 45 seconds to an inactive sham and active TENS to determine the degree of blinding and influence on pain reduction. Pressure-pain thresholds (PPT), heat-pain thresholds (HPT), and pain intensities to tonic heat and pressure were measured in 69 healthy adults before and after randomization. Allocation investigators and subjects were asked to identify the treatment administered. The transient sham blinded investigators 100% of the time and 40% of subjects compared to the inactive sham that blinded investigators 0% of the time and 21% of subjects. Investigators and subjects were blinded only 7% and 13% of the time, respectively, with active TENS. Neither placebo treatment resulted in significant changes in PPT, HPT, or pain intensities. Subjects using higher active TENS amplitudes (> or =17 mAs) had significantly higher PPTs and lower pain intensities to tonic pressure than subjects using lower amplitudes (<17 mAs). HPTs and pain intensities to tonic heat were not significantly changed. The transient TENS completely blinds investigators to treatment and does not reduce pain, thereby providing a true placebo treatment. PERSPECTIVE: This article presents the benefits of a new transient sham TENS device for use in prospective, randomized, clinical trials. This device facilitates blinding of subjects and investigators to eliminate expectation bias and determine the true efficacy of TENS for use in clinical populations.

Indexed as

Placebo EffectPlacebosAdultClinical Trials as TopicDouble-Blind MethodElectronics, MedicalFemaleHumansMaleObserver VariationPainPain ManagementPain MeasurementResearch DesignTranscutaneous Electric Nerve StimulationPlacebos

Identifiers

PMID19945354
PMCPMC2922105
OpenAlexW1976788064

What OpenQuestion holds

Textmetadata
LicenceTDM
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.