Fibromyalgia
Conditions
Keywords
transcranial static magnetic field stimulation, fibromyalgia, pain
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.
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.
Interventions
The intervention group will receive a treatment of tSMS in the primary motor cortex.
PROCEDURESham transcranial static magnetic field stimulation
The placebo group will receive a dummy treatment
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Self-reported pain intensity | 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). |
| Change from Self-reported quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Global health | 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). |
| Change from 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) | Cognitive impairment evaluated by the Multidimensional Inventory of Subjective Cognitive Impairment. |
| Change from Self-reported catastrophizing | 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. |
| Change from Sleep | 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. |
| Change from Physical activity | 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. |
| Change from Depression | 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. |
| Change from Confidence in the treatment | 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. |
Countries
Spain
Outcome results
None listed