Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study

Conditions
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Fibromyalgia

Intervention / Treatment
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* Procedure: transcranial static magnetic field stimulation (tSMS)
* Procedure: Sham transcranial static magnetic field stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: transcranial static magnetic field stimulation (tSMS)<br>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)<br>* The intervention group will receive a treatment of tSMS in the primary motor cortex.<br>|
| Sham Comparator: Sham transcranial static magnetic field stimulation<br>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<br>* The placebo group will receive a dummy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Self-reported pain intensity | Self-reported pain intensity evaluated by the Visual Analogue Scale (VAS). | 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 Self-reported quality of life | Self-reported quality of life evaluated by the Fibromyalgia Impact Questionnaire (FIQ). | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Self-reported catastrophizing | 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. | 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 Confidence in the treatment | Confidence in the treatment evaluated by the Patient Global Impression of Change. | 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 Global health | Self-reported Global health evaluated by the Short form-36 (SF-36). | 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 Cognitive impairment | Cognitive impairment evaluated by the Multidimensional Inventory of Subjective Cognitive Impairment. | 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 Depression | 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. | 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 | 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. | 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 Physical activity | Change from Physical activity evaluated by the International Physical Activity Questionnaire. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial static magnetic field stimulation, fibromyalgia, pain