Evidence map›Paper›PMID 36036838›Full record

ArticlePhysical therapy2022

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.

Andrew A Post, Dana L Dailey, Emine O Bayman, Ruth L Chimenti, Michele Costigan, Carla Franck, Trevis Huff, Elizabeth Johnson, Maxine Koepp, David-Erick Lafontant and 8 more

Open access · bronzeAbstract readClinical Trial Protocol
In one paragraph

Article in Physical therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 27% 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

9 citing papers in PubMed, 8 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

18 authors at 2 institutions in 1 country.

Andrew A PostDepartment of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.ORCID 0000-0001-6907-3361
Dana L DaileyDepartment of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.
Emine O BaymanThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Ruth L ChimentiDepartment of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.ORCID 0000-0002-0514-739X
Michele CostiganThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Carla FranckKepros Physical Therapy, Cedar Rapids, Iowa, USA.
Trevis HuffThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Elizabeth JohnsonVanderbilt University Medical Center, Division of Rheumatology and Immunology, Nashville, Tennessee, USA.
Maxine KoeppThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
David-Erick LafontantThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Megan E McCabeThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Tina Neill-HudsonThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Carol G T VanceDepartment of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.
Barb Van GorpDepartment of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.
Bridget M ZimmermanThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Dixie EcklundThe University of Iowa Clinical Trials Statistical and Data Management Center, Iowa City Iowa, USA.
Leslie J CroffordVanderbilt University Medical Center, Division of Rheumatology and Immunology, Nashville, Tennessee, USA.
Kathleen A SlukaDepartment of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.ORCID 0000-0003-0207-8728
University of Iowa · USVanderbilt University Medical Center · US

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
Fibromyalgia TENS in Physical Therapy Study (TIPS): an embedded pragmatic clinical trial: Administrative SupplementUH3AR076387 · NIAMS · UNIVERSITY OF IOWA · PI CROFFORD, LESLIE J, SLUKA, KATHLEEN A · 2020 to 2023
$7.3M
HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics SupplementU24AT010961 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2019 to 2021
$6.4M
Fibromyalgia TENS in Physical Therapy Study (TIPS):an embedded pragmatic clinical trialUG3AR076387 · NIAMS · UNIVERSITY OF IOWA · PI CROFFORD, LESLIE J, SLUKA, KATHLEEN A · 2019 to 2019
$738k
NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24 AT010961NIAMS NIH HHS UG3 AR076387NIAMS NIH HHS UH3 AR076387
6 · The paper itself

Abstract

objectivesTranscutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting.

methodsFibromyalgia TENS in Physical Therapy Study is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to day 60 on an 11-point numeric rating scale when participants sit and stand 5 times (Sit and Stand Test). Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the Helping to End Addiction Long-Term Initiative. IMPACT: The findings from this study will provide effectiveness data on TENS for individuals with fibromyalgia for health care policymakers, clinicians, and insurers. Data from this study will also inform future pragmatic trials for nonpharmacological interventions and chronic musculoskeletal pain conditions.

Indexed as

FibromyalgiaTranscutaneous Electric Nerve StimulationFatigueHumansPainPain ManagementPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicChronic PainFibromyalgiaPragmaticTENSTranscutaneous Electrical Nerve Stimulation

Identifiers

PMID36036838
PMCPMC10071449
OpenAlexW4293457623

What OpenQuestion holds

Textmetadata
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.