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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
The intervention group will receive a treatment of tSMS in the primary motor cortex.
The placebo group will receive a dummy treatment
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Seville, Spain
Change from Self-reported pain intensity
Self-reported pain intensity evaluated by the Visual Analogue Scale (VAS).
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 Self-reported quality of life
Self-reported quality of life evaluated by the Fibromyalgia Impact Questionnaire (FIQ).
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 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.
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 Confidence in the treatment
Confidence in the treatment evaluated by the Patient Global Impression of Change.
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 Global health
Self-reported Global health evaluated by the Short form-36 (SF-36).
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from Cognitive impairment
Cognitive impairment evaluated by the Multidimensional Inventory of Subjective 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)
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.
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
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.
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 Physical activity
Change from Physical activity evaluated by the International Physical Activity Questionnaire.
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)