Fibromyalgia Clinical Trial
— TSMFS-FMSOfficial title:
Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study
Verified date | June 2022 |
Source | University of Seville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 30, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla | Sevilla |
Lead Sponsor | Collaborator |
---|---|
University of Seville |
Spain,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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