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Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome (TSMFS-FMS)

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ClinicalTrials.gov Identifier: NCT04836325
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
JJ JIMENEZ-REJANO, University of Seville

Brief Summary:
The main objective is to know if the transcranial static magnetic field stimulation (tSMS) reduces the perception of pain in patients with fibromyalgia and its effect on health-related quality of life. In addition, it will seek to limit the parameters necessary to achieve efficiency with the technique.

Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: transcranial static magnetic field stimulation (tSMS) Procedure: Sham transcranial static magnetic field stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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.
Procedure: transcranial static magnetic field stimulation (tSMS)
The intervention group will receive a treatment of tSMS in the primary motor cortex.

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.
Procedure: Sham transcranial static magnetic field stimulation
The placebo group will receive a dummy treatment




Primary Outcome Measures :
  1. 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) ]
    Self-reported pain intensity evaluated by the Visual Analogue Scale (VAS).

  2. 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) ]
    Self-reported quality of life evaluated by the Fibromyalgia Impact Questionnaire (FIQ).


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    Confidence in the treatment evaluated by the Patient Global Impression of Change.

  3. 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) ]
    Self-reported Global health evaluated by the Short form-36 (SF-36).

  4. 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) ]
    Cognitive impairment evaluated by the Multidimensional Inventory of Subjective Cognitive Impairment.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. 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) ]
    Change from Physical activity evaluated by the International Physical Activity Questionnaire.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836325


Contacts
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Contact: MANUEL DEL-VALLE-GRATACOS, Physiotherapist +34620929871 manu-valle@hotmail.com

Locations
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Spain
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla Recruiting
Sevilla, Spain, 41009
Contact: JOSE J. JIMENEZ-REJANO, PhD    +34667309369    jjjimenez@us.es   
Principal Investigator: MANUEL DEL-VALLE-GRATACOS, Physiotherapist         
Sub-Investigator: SAMUEL JIMENEZ-JIMENEZ, Phd         
Sub-Investigator: ANTONIO OLIVIERO, Neurologist         
Sponsors and Collaborators
University of Seville
Investigators
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Study Director: JOSE-JESUS JIMENEZ-REJANO, PhD University of Seville
Publications of Results:

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Responsible Party: JJ JIMENEZ-REJANO, PhD, University of Seville
ClinicalTrials.gov Identifier: NCT04836325    
Other Study ID Numbers: JJJimenez-Rejano, USeville
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JJ JIMENEZ-REJANO, University of Seville:
transcranial static magnetic field stimulation
fibromyalgia
pain
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases