- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04836325
Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome (TSMFS-FMS)
Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study
Study Overview
Status
Conditions
Detailed Description
Background:
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sevilla, Spain, 41009
- Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Formal diagnosis of fibromyalgia syndrome (FMS).
- 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:
- Presence of concomitant autoimmune or hematologic diseases.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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The intervention group will receive a treatment of tSMS in the primary motor cortex.
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Sham Comparator: 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.
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The placebo group will receive a dummy treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Self-reported pain intensity
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
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Self-reported pain intensity evaluated by the Visual Analogue Scale (VAS).
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
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Change from Self-reported quality of life
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Self-reported quality of life evaluated by the Fibromyalgia Impact Questionnaire (FIQ).
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Self-reported catastrophizing
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Self-reported catastrophizing evaluated by the Pain Catastrophizing Scale: 13 items, using the 0 (not at all) to 4 (all the time) scale.
A total score is yielded (ranging from 0-52), the worse the result the higher the score.
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Confidence in the treatment
Time Frame: After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Confidence in the treatment evaluated by the Patient Global Impression of Change.
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After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Global health
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Self-reported Global health evaluated by the Short form-36 (SF-36).
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Cognitive impairment
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Cognitive impairment evaluated by the Multidimensional Inventory of Subjective Cognitive Impairment.
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Depression
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Depression Evaluated by the Hospital Anxiety and Depression Scale: 14 items, 7 for depression and 7 for anxiety.
Each item had been answered by the patient on a four-point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, the worse the result the higher the score.
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Sleep
Time Frame: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Sleep evaluated by the Medical Outcomes Study Sleep Scale:12 Likert-type items with 6 degrees of response (from 1-always to 6-never).
For its interpretation, a gross estimate of the amount of sleep is obtained (item 2) and scores in the different subscales.
The direct scores are transformed into a scale from 0 to 100, with no cut-off points; the higher the score, the greater the intensity of the concept evaluated.
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At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
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Change from Physical activity
Time Frame: After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
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Change from Physical activity evaluated by the International Physical Activity Questionnaire.
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After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: JOSE-JESUS JIMENEZ-REJANO, PhD, University of Seville
Publications and helpful links
General Publications
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- 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. Erratum In: Schmerz. 2017 Sep 7;: German.
- Wolfe F, Walitt B. Culture, science and the changing nature of fibromyalgia. Nat Rev Rheumatol. 2013 Dec;9(12):751-5. doi: 10.1038/nrrheum.2013.96. Epub 2013 Jul 2.
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
- Serra J, Collado A, Sola R, Antonelli F, Torres X, Salgueiro M, Quiles C, Bostock H. Hyperexcitable C nociceptors in fibromyalgia. Ann Neurol. 2014 Feb;75(2):196-208. doi: 10.1002/ana.24065. Epub 2014 Feb 12.
- Gentile E, Ricci K, Delussi M, Brighina F, de Tommaso M. Motor Cortex Function in Fibromyalgia: A Study by Functional Near-Infrared Spectroscopy. Pain Res Treat. 2019 Jan 16;2019:2623161. doi: 10.1155/2019/2623161. eCollection 2019.
- Di Lazzaro V, Oliviero A, Pilato F, Saturno E, Dileone M, Mazzone P, Insola A, Tonali PA, Rothwell JC. The physiological basis of transcranial motor cortex stimulation in conscious humans. Clin Neurophysiol. 2004 Feb;115(2):255-66. doi: 10.1016/j.clinph.2003.10.009.
- Groppa S, Oliviero A, Eisen A, Quartarone A, Cohen LG, Mall V, Kaelin-Lang A, Mima T, Rossi S, Thickbroom GW, Rossini PM, Ziemann U, Valls-Sole J, Siebner HR. A practical guide to diagnostic transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2012 May;123(5):858-82. doi: 10.1016/j.clinph.2012.01.010. Epub 2012 Feb 19.
- Capone F, Dileone M, Profice P, Pilato F, Musumeci G, Minicuci G, Ranieri F, Cadossi R, Setti S, Tonali PA, Di Lazzaro V. Does exposure to extremely low frequency magnetic fields produce functional changes in human brain? J Neural Transm (Vienna). 2009 Mar;116(3):257-65. doi: 10.1007/s00702-009-0184-2. Epub 2009 Feb 3.
- 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.
- Oliviero A, Carrasco-Lopez MC, Campolo M, Perez-Borrego YA, Soto-Leon V, Gonzalez-Rosa JJ, Higuero AM, Strange BA, Abad-Rodriguez J, Foffani G. Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex. Brain Stimul. 2015 May-Jun;8(3):481-5. doi: 10.1016/j.brs.2014.12.002. Epub 2014 Dec 11.
- 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.
- Lloyd DM, Wittkopf PG, Arendsen LJ, Jones AKP. Is Transcranial Direct Current Stimulation (tDCS) Effective for the Treatment of Pain in Fibromyalgia? A Systematic Review and Meta-Analysis. J Pain. 2020 Nov-Dec;21(11-12):1085-1100. doi: 10.1016/j.jpain.2020.01.003. Epub 2020 Jan 23.
- Paolucci T, Piccinini G, Iosa M, Piermattei C, de Angelis S, Grasso MR, Zangrando F, Saraceni VM. Efficacy of extremely low-frequency magnetic field in fibromyalgia pain: A pilot study. J Rehabil Res Dev. 2016;53(6):1023-1034. doi: 10.1682/JRRD.2015.04.0061.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JJJimenez-Rejano, USeville
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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