Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome
NCT ID: NCT04836325
Last Updated: 2022-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2021-04-19
2021-11-30
Brief Summary
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Detailed Description
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Various non-invasive brain stimulation techniques have been successfully tested in fibromyalgia syndrome (FMS). Transcranial static magnetic field stimulation (tSMS) is a new, portable and inexpensive non invasive brain stimulation (NIBS) technique that has shown security, biological effects, and therapeutical effects in some pathologies. Some studies have studied its effect in pain central processing, our aim is to study its effect on FMS. The safety that tSMS has demonstrated in several clinical trials opens doors to future clinical trials that will extend its clinical utility.
Objectives:
To investigate the effect of tSMS on pain in patients with FMS, using subjective and objective assessment measures. Identify dose response to the treatment to limit the parameters required to achieve effectiveness with the technique.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental: transcranial static magnetic field stimulation (tSMS)
The intervention group will receive a treatment of Transcranial Static Magnetic Field Stimulation (tSMS) in the primary motor cortex with a duration of 30 minutes, 5 times a week, during 4 weeks, for a total of 20 sessions.
transcranial static magnetic field stimulation (tSMS)
The intervention group will receive a treatment of tSMS in the primary motor cortex.
Sham transcranial static magnetic field stimulation
The placebo group will receive a dummy treatment with a duration of 30 minutes, 5 times a week, during 4 weeks, for a total of 20 sessions.
Sham transcranial static magnetic field stimulation
The placebo group will receive a dummy treatment
Interventions
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transcranial static magnetic field stimulation (tSMS)
The intervention group will receive a treatment of tSMS in the primary motor cortex.
Sham transcranial static magnetic field stimulation
The placebo group will receive a dummy treatment
Eligibility Criteria
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Inclusion Criteria
* No change in the last 4 weeks on their standard treatment.
* They must have pain for more than 6 months (at least 4 on the VAS scale).
* Score on the fibromyalgia impact questionnaire (FIQ) greater than 39.
Exclusion Criteria
* Neuropsychiatric disorders.
* Pacemakers or neurostimulators implants.
* Substance abuse or other pathologies that can explain chronic pain.
* Pregnant or lactating women.
* Those who are receiving any other type of physiotherapy treatment.
18 Years
75 Years
ALL
No
Sponsors
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University of Seville
OTHER
Responsible Party
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JJ JIMENEZ-REJANO
PhD
Principal Investigators
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JOSE-JESUS JIMENEZ-REJANO, PhD
Role: STUDY_DIRECTOR
University of Seville
Locations
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Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Seville, , Spain
Countries
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References
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Eich W, Bar KJ, Bernateck M, Burgmer M, Dexl C, Petzke F, Sommer C, Winkelmann A, Hauser W. [Definition, classification, clinical diagnosis and prognosis of fibromyalgia syndrome : Updated guidelines 2017 and overview of systematic review articles]. Schmerz. 2017 Jun;31(3):231-238. doi: 10.1007/s00482-017-0200-7. German.
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Capone F, Pellegrino G, Motolese F, Rossi M, Musumeci G, Di Lazzaro V. Extremely Low Frequency Magnetic Fields Do Not Affect LTP-Like Plasticity in Healthy Humans. Front Hum Neurosci. 2020 Feb 5;14:14. doi: 10.3389/fnhum.2020.00014. eCollection 2020.
Oliviero A, Mordillo-Mateos L, Arias P, Panyavin I, Foffani G, Aguilar J. Transcranial static magnetic field stimulation of the human motor cortex. J Physiol. 2011 Oct 15;589(Pt 20):4949-58. doi: 10.1113/jphysiol.2011.211953. Epub 2011 Aug 1.
Shibata S, Watanabe T, Yukawa Y, Minakuchi M, Shimomura R, Mima T. Effect of transcranial static magnetic stimulation on intracortical excitability in the contralateral primary motor cortex. Neurosci Lett. 2020 Apr 1;723:134871. doi: 10.1016/j.neulet.2020.134871. Epub 2020 Feb 25.
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Dileone M, Mordillo-Mateos L, Oliviero A, Foffani G. Long-lasting effects of transcranial static magnetic field stimulation on motor cortex excitability. Brain Stimul. 2018 Jul-Aug;11(4):676-688. doi: 10.1016/j.brs.2018.02.005. Epub 2018 Feb 7.
Kirimoto H, Tamaki H, Otsuru N, Yamashiro K, Onishi H, Nojima I, Oliviero A. Transcranial Static Magnetic Field Stimulation over the Primary Motor Cortex Induces Plastic Changes in Cortical Nociceptive Processing. Front Hum Neurosci. 2018 Feb 15;12:63. doi: 10.3389/fnhum.2018.00063. eCollection 2018.
Knijnik LM, Dussan-Sarria JA, Rozisky JR, Torres IL, Brunoni AR, Fregni F, Caumo W. Repetitive Transcranial Magnetic Stimulation for Fibromyalgia: Systematic Review and Meta-Analysis. Pain Pract. 2016 Mar;16(3):294-304. doi: 10.1111/papr.12276. Epub 2015 Jan 12.
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Kirimoto H, Tamaki H, Matsumoto T, Sugawara K, Suzuki M, Oyama M, Onishi H. Effect of transcranial static magnetic field stimulation over the sensorimotor cortex on somatosensory evoked potentials in humans. Brain Stimul. 2014 Nov-Dec;7(6):836-40. doi: 10.1016/j.brs.2014.09.016. Epub 2014 Sep 30.
Kirimoto H, Asao A, Tamaki H, Onishi H. Non-invasive modulation of somatosensory evoked potentials by the application of static magnetic fields over the primary and supplementary motor cortices. Sci Rep. 2016 Oct 4;6:34509. doi: 10.1038/srep34509.
Other Identifiers
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JJJimenez-Rejano, USeville
Identifier Type: -
Identifier Source: org_study_id
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