Evidence map›Paper›PMID 25212518›Full record

Trial reportPhysical therapy2015

Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial.

Brian Noehren, Dana L Dailey, Barbara A Rakel, Carol G T Vance, Miriam B Zimmerman, Leslie J Crofford, Kathleen A Sluka

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Physical therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01888640 (Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 12% 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 map

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

TypeinterventionalSponsorKathleen SlukaRan2013 to 2018Enrolled301ConditionsFibromyalgiaArmsTENS
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  7. Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
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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

7 authors at 4 institutions in 1 country.

Brian NoehrenB. Noehren, PT, PhD, Division of Physical Therapy, College of Health Sciences University of Kentucky, Lexington, Kentucky.
Dana L DaileyD.L. Dailey, PT, PhD, Department of Physical Therapy and Rehabilitation Science, College of Medicine, University of Iowa, Iowa City, Iowa.
Barbara A RakelB.A. Rakel, RN, PhD, College of Nursing, University of Iowa.
Carol G T VanceC.G.T. Vance, PT, PhD, Department of Physical Therapy and Rehabilitation Science, College of Medicine, University of Iowa.
Miriam B ZimmermanM.B. Zimmerman, PhD, Biostatistics, University of Iowa.
Leslie J CroffordL.J. Crofford, MD, Department of Medicine, Vanderbilt University, Nashville, Tennessee.
Kathleen A SlukaK.A. Sluka, PT, PhD, FAPTA, Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA 52422-1089 (USA). kathleen-sluka@uiowa.edu.
University of Iowa · USUniversity of Kentucky · USVanderbilt University · USZimmerman Associates (United States) · US

Funding

Fibromyalgia Activity Study with TENS "FAST"UM1AR063381 · NIAMS · UNIVERSITY OF IOWA · PI CROFFORD, LESLIE J, SLUKA, KATHLEEN A · 2013 to 2017
$3.4M
Effectiveness of TENS on FibromyalgiaR34AR060278 · NIAMS · UNIVERSITY OF IOWA · PI SLUKA, KATHLEEN A · 2011 to 2011
$162k
NIAMS NIH HHS R34 AR060278NIAMS NIH HHS UM1 AR063381
6 · The paper itself

Abstract

backgroundFibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.

objectivesThe purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.

designThis will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.

participantsThree hundred forty-three participants with fibromyalgia will be recruited for this study.

interventionParticipants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity. MEASUREMENTS: The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing. LIMITATIONS: Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.

conclusionsThe results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.

Indexed as

Quality of LifeTranscutaneous Electric Nerve StimulationDouble-Blind MethodFatigueFemaleFibromyalgiaHumansPain Measurement

Identifiers

PMID25212518
PMCPMC4295083
OpenAlexW2167125832

What OpenQuestion holds

Textmetadata
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.