Evidence map›Paper›PMID 31672712›Full record

ArticleBMJ open2019

Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol.

Luis Castelo-Branco, Elif Uygur Kucukseymen, Dante Duarte, Mirret M El-Hagrassy, Camila Bonin Pinto, Muhammed Enes Gunduz, Alejandra Cardenas-Rojas, Kevin Pacheco-Barrios, Yiling Yang, Paola Gonzalez-Mego and 6 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT03371225 nacompletednot on this map

Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System

TypeinterventionalSponsorSpaulding Rehabilitation HospitalRan2019 to 2025Enrolled116ConditionsFibromyalgiaArmsActive tDCS, Active Exercise, Sham tDCS, Sham Exercise
NCT07239427 narecruitingnot on this mapstarted 2025, after this paper: background citation

Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.

TypeinterventionalSponsorUniversity of ValladolidRan2025 to 2026Enrolled68ConditionsFibromyalgiaArmsPain Science Education, Transcranial Direct Current Stimulation, Therapeutic Exercise, Sham Transcranial Direct Current Stimulation
NCT07323199 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

High-Intensity Interval Training (HIIT) and Transcranial Direct Current Stimulation (tDCS) in Women With Fibromyalgia - Effects on Clinical and Neuro-physiological Variables: Randomized Clinical Trial Protocol

TypeinterventionalSponsorUniversidad Nacional Andres BelloRan2026 to 2027Enrolled40ConditionsFibromyalgia (FM)ArmsEXERCISE TRAINING WITH OR WITHOUT MEDICATION, Neuromodulators
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Decreased neural inhibitory state in fibromyalgia pain: A cross-sectional study.Neurophysiologie clinique = Clinical neurophysiology · 2020
    Trial
  6. Article
  7. Therapeutic approach to fibromyalgia: a consensus statement on pharmacological and non-pharmacological treatment from the neuropathic pain special interest group of the Italian neurological society.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Article
  8. Review
  9. Article
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  11. Review
  12. Review
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  14. Cross-sectional and longitudinal analysis of conditioned pain modulation and pain in fibromyalgia: CPM as an effect modifier of pain changes over time.Physiotherapy research international : the journal for researchers and clinicians in physical therapy · 2024
    Article
  15. Review
  16. Article
  17. Article
  18. Temporal Summation in Fibromyalgia Patients: Comparing Phasic and Tonic Paradigms.Frontiers in pain research (Lausanne, Switzerland) · 2022
    Article
  19. Article
  20. Article
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

16 authors at 2 institutions in 2 countries.

Luis Castelo-BrancoNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Elif Uygur KucukseymenNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-6190-106X
Dante DuarteNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Mirret M El-HagrassyNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Camila Bonin PintoNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Muhammed Enes GunduzNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Alejandra Cardenas-RojasNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-8464-6866
Kevin Pacheco-BarriosNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Yiling YangNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Paola Gonzalez-MegoNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-2382-2061
Anayali Estudillo-GuerraNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Ludmilla Candido-SantosNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Ines Mesia-ToledoNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Haley RaffertyNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Wolnei CaumoLaboratory of Pain & Neuromodulation, Hospital de Clinicas de Porto Alegre da Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Felipe FregniNeuromodulation Center/Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts, USA fregni.felipe@mgh.harvard.edu.
Harvard University · USUniversidade Federal do Rio Grande do Sul · BR

Funding

Optimized tDCS for fibromyalgia: targeting the endogenous pain control systemR01AT009491 · NCCIH · SPAULDING REHABILITATION HOSPITAL · PI FREGNI, FELIPE · 2018 to 2023
$2.3M
NCCIH NIH HHS R01 AT009491
6 · The paper itself

Abstract

introductionFibromyalgia (FM) is a common debilitating condition with limited therapeutic options. Medications have low efficacy and are often associated with adverse effects. Given that FM is associated with a defective endogenous pain control system and central sensitisation, combining interventions such as transcranial direct current stimulation (tDCS) and aerobic exercise (AE) to modulate pain-processing circuits may enhance pain control. METHODS AND ANALYSIS: A prospective, randomised (1:1:1:1), placebo-controlled, double-blind, factorial clinical trial will test the hypothesis that optimised tDCS (16 anodal tDCS sessions combined with AE) can restore of the pain endogenous control system. Participants with FM (n=148) will undergo a conditioning exercise period and be randomly allocated to one of four groups: (1) active tDCS and AE, (2) sham tDCS and AE, (3) active tDCS and non-aerobic exercise (nAE) or (4) sham tDCS and nAE. Pain inhibitory activity will be assessed using conditioned pain modulation (CPM) and temporal slow pain summation (TSPS)-primary outcomes. Secondary outcomes will include the following assessments: Transcranial magnetic stimulation and electroencephalography as cortical markers of pain inhibitory control and thalamocortical circuits; secondary clinical outcomes on pain, FM, quality of life, sleep and depression. Finally, the relationship between the two main mechanistic targets in this study-CPM and TSPS-and changes in secondary clinical outcomes will be tested. The change in the primary efficacy endpoint, CPM and TSPS, from baseline to week 4 of stimulation will be tested with a mixed linear model and adjusted for important demographic variables. ETHICS AND DISSEMINATION: This study obeys the Declaration of Helsinki and was approved by the Institutional Review Board (IRB) of Partners Healthcare under the protocol number 2017P002524. Informed consent will be obtained from participants. Study findings will be reported in conferences and peer-reviewed journal publications. TRIAL REGISTRATION NUMBER: NCT03371225.

Indexed as

AdultDouble-Blind MethodExercise TherapyFemaleFibromyalgiaHumansMaleMiddle AgedPain ManagementProspective StudiesRandomized Controlled Trials as TopicTranscranial Direct Current StimulationYoung Adultaerobic exerciseconditioned pain modulationendogenous pain control systemfibromyalgiatemporal slow pain summationtranscranial direct current stimulation

Identifiers

PMID31672712
PMCPMC6830717
OpenAlexW2982365398

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.